MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM LARGE BORE 71 CATHETER; CATHETER, ASPIRATION CATHETER

Model Number IC71132UG

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a thrombectomy procedure targeting an m1 occlusion, the 132cm large bore catheter 71 (lbc) (ic71132ug / 30526888) was advanced through the 6fr flexor® shuttle® guiding sheath (cook medical) over a rebar¿ 18 microcatheter (medtronic) and synchro2¿ standard guidewire (stryker) to the m1 for clot removal.During the advancement through the internal carotid artery (ica), the physician felt that it was hard to advance the lbc after multiple attempts.He struggled to withdraw the lbc as well.Upon removal from the shuttle guiding sheath, he observed that the distal end of the lbc catheter had kinked and stretched.The physician then pulled a second lbc catheter, another 132cm large bore catheter 71 (lbc) (ic71132ug / 30526886), and the exact same scenario as with the first lbc catheter occurred.The physician then proceeded with an ace¿ 60 reperfusion catheter (penumbra), which was not able to reach the clot in the m1 segment.The physician then advanced the synchro guidewire and the rebar 18 microcatheter into the m1, removed the synchro guidewire and advanced a 5mm x 37mm embotrap iii revascularization device (et309537) into the clot.The physician tried to advance the ace 60 reperfusion catheter with the embotrap iii device deployed but was unsuccessful in advancing the ace 60 reperfusion to the face of the clot.The procedure was completed after this final pass.There was no patient adverse event or patient complication reported.On 15-jun-2022, a response from the cerenovus representative stating that there was no performance issue or device malfunction associated with the embotrap iii device.It was reported that the embotrap iii device performed ¿perfectly.¿ on 21-jun-2022, additional information was received.The information included two images that captured the vessel tortuosity, the acute bend in the distal cervical ica segment.The information indicated that the physician was attempting the adapt (direct aspiration first pass technique) first then switched to stent-retriever with co-aspiration if needed, which in this case, it was.It is unknown in this instance, if the large bore catheters (lbc) devices were advanced with the wire and the microcatheter, but it was reported that the physician typically does advance over the microcatheter and wire.There was no damage noted on the 6fr cook shuttle.There was no device performance issue / malfunction associated with the embotrap iii device.The information also clarified the statement documented in the complaint, ¿the et iii was used and deployed but unsuccessful in advancing to the face of the clot.¿ the clarification is as follows: ¿the rebar 18 microcatheter tracked to the clot over a synchro wire which was removed and replaced with the etiii.The embotrap was deployed within the clot, he then tried to advance the ace 60 to the face of the clot but was unsuccessful in doing so.The embotrap performed perfectly.¿ with this successful deployment within the clot, it was the final pass and the procedure was completed.It was unknown if continuous flush was maintained through the microcatheter.The information indicated that there was a delay due to the two (2) unsuccessful attempts to navigate the lbc to the face of the clot.The duration of the delay was not reported, but it was not deemed clinically significant and there was no patient adverse event.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The two images were reviewed by underwent independent physician review on 04-jul-2022.The results of the physician review are documented as follows: ¿the description of the case suggests an anatomical obstruction which can either be an acute loop in the artery or vasospasm.The images provided show indeed both and this may have caused the catheter to be ¿fixed¿ and difficult to remove.Depending on how much forward pressure was delivered, there is a chance that the lbc will kink.The fact that all three catheters were unable to pass (lbc 2x, ace 60) support the anatomical challenge.Investigation of the lbc device may help understand how and where the kinking took place.¿ physician name and date reviewed: (b)(6) md, neurointerventionalist.04-jul-2022.A review of manufacturing documentation associated with this lot (30526888) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00445.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 08-aug-2022.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00445.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a thrombectomy procedure targeting an m1 occlusion, the 132cm large bore catheter 71 (lbc) (ic71132ug / 30526888) was advanced through the 6fr flexor® shuttle® guiding sheath (cook medical) over a rebar¿ 18 microcatheter (medtronic) and synchro2¿ standard guidewire (stryker) to the m1 for clot removal.During the advancement through the internal carotid artery (ica), the physician felt that it was hard to advance the lbc after multiple attempts.He struggled to withdraw the lbc as well.Upon removal from the shuttle guiding sheath, he observed that the distal end of the lbc catheter had kinked and stretched.The physician then pulled a second lbc catheter, another 132cm large bore catheter 71 (lbc) (ic71132ug / 30526886), and the exact same scenario as with the first lbc catheter occurred.The physician then proceeded with an ace¿ 60 reperfusion catheter (penumbra), which was not able to reach the clot in the m1 segment.The physician then advanced the synchro guidewire and the rebar 18 microcatheter into the m1, removed the synchro guidewire and advanced a 5mm x 37mm embotrap iii revascularization device (et309537) into the clot.The physician tried to advance the ace 60 reperfusion catheter with the embotrap iii device deployed but was unsuccessful in advancing the ace 60 reperfusion to the face of the clot.The procedure was completed after this final pass.There was no patient adverse event or patient complication reported.On 15-jun-2022, a response from the cerenovus representative stating that there was no performance issue or device malfunction associated with the embotrap iii device.It was reported that the embotrap iii device performed ¿perfectly.¿ on 21-jun-2022, additional information was received.The information included two images that captured the vessel tortuosity, the acute bend in the distal cervical ica segment.The information indicated that the physician was attempting the adapt (direct aspiration first pass technique) first then switched to stent-retriever with co-aspiration if needed, which in this case, it was.It is unknown in this instance, if the large bore catheters (lbc) devices were advanced with the wire and the microcatheter, but it was reported that the physician typically does advance over the microcatheter and wire.There was no damage noted on the 6fr cook shuttle.There was no device performance issue / malfunction associated with the embotrap iii device.The information also clarified the statement documented in the complaint, ¿the et iii was used and deployed but unsuccessful in advancing to the face of the clot.¿ the clarification is as follows: ¿the rebar 18 microcatheter tracked to the clot over a synchro wire which was removed and replaced with the etiii.The embotrap was deployed within the clot, he then tried to advance the ace 60 to the face of the clot but was unsuccessful in doing so.The embotrap performed perfectly.¿ with this successful deployment within the clot, it was the final pass and the procedure was completed.It was unknown if continuous flush was maintained through the microcatheter.The information indicated that there was a delay due to the two (2) unsuccessful attempts to navigate the lbc to the face of the clot.The duration of the delay was not reported, but it was not deemed clinically significant and there was no patient adverse event.The two images were reviewed by underwent independent physician review on 04-jul-2022.The results of the physician review are documented as follows: ¿the description of the case suggests an anatomical obstruction which can either be an acute loop in the artery or vasospasm.The images provided show indeed both and this may have caused the catheter to be ¿fixed¿ and difficult to remove.Depending on how much forward pressure was delivered, there is a chance that the lbc will kink.The fact that all three catheters were unable to pass (lbc 2x, ace 60) support the anatomical challenge.Investigation of the lbc device may help understand how and where the kinking took place.¿ physician name and date reviewed: (b)(6), md, neurointerventionalist.On (b)(6) 2022.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 132cm large bore catheter 71 (lbc) was received contained in the decontamination pouch.Visual inspection was performed.The presence of the hydrophilic coating was confirmed.The body of the device was observed with a compressed section starting at 46 inches to 48 inches from the proximal end.The lbc was also observed to be stretched at the distal portion.Further inspection was performed under microscopic magnification which revealed that as a result of the stretched noted at the distal portion, the mesh structure was exposed.The coating was observed to have a severely stretched appearance.The catheter was then flushed to check for possible leaks, but no leak was observed from the stretched area.The outer diameter (od) of the undamaged section of the device was measured and confirmed to be within specification.The issue reported in the complaint that the physician felt that it was hard to advance the lbc could not be duplicated in the lab since such issue is most likely related to the patient¿s anatomy, device manipulation, and/or device selection.The review of the procedural images suggested patient and anatomical factors ¿the description of the case suggests an anatomical obstruction which can either be an acute loop in the artery or vasospasm.¿ which might have contributed to the tracking difficulty as reported in the complaint.However, the returned catheter does not show evidence of damage consistent with tracking difficulty such as catheter kinking.Similar to the tracking difficulty, the withdrawal difficulty documented in the complaint is most specific to the patient at the procedure time, but the stretched appearance of the returned catheter seems to be a translation of the difficult to withdraw the device.The reported issues related to the difficulty encountered during the attempt to advance the catheter through the ica and the catheter kinking could not be confirmed based on the appearance of the returned catheter.The reported issue related to the withdrawal difficulty and catheter stretching was confirmed based on the stretched portion noted on the catheter.The compressed condition noted in the returned catheter was not originally reported in the complaint, and the exact timing when this condition occurred cannot be determined since it could have contributed to the issues encountered during the procedure or could be related to post-operative factors.There is no indication that the issue reported in the complaint is the result of an inherently device-related defect.A review of manufacturing documentation associated with this lot (30526888) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue reported in the complaint was confirmed based on the evidence observed on the body of the device.The multiple damages found on the device may have been the result of the difficulty experienced while advancing or maneuvering the catheter during the procedure.Factors such as the patient¿s anatomy, as reported in the complaint, may have contributed to the tracking difficulty, which ultimately might have led to the kinked condition observed on the device.With the limited information available and the evidence obtained from the device inspection, there is no clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) contains the following precautions: carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a device that has been damaged in any way; replace with another large bore catheter.A damaged device may cause complications.Exercise care in handling the large bore catheter to reduce the chance of accidental damage.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.H.6: the code ¿no device problem found (c19)¿ was used in the investigation findings because the issue tracking difficulty could not be duplicated in the product analysis laboratory.This code corresponds to the ¿cause not established (d15)¿ in the investigation conclusion.The code ¿no device problem found (c19)¿ was used in the investigation findings because the reported issue that the lbc kinked could not be confirmed based on the appearance of the returned catheter.This code corresponds to the ¿no problem detected (d14)¿ in the investigation conclusion.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00444 and 3008114965-2022-00445.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: 132CM LARGE BORE 71 CATHETER
• Type of Device: CATHETER, ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF INC.(MIRAMAR); 3260 executive way; miramar FL 33025
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14916509
• MDR Text Key: 302789479
• Report Number: 3008114965-2022-00444
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082378
• UDI-Public: 10886704082378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IC71132UG
• Device Catalogue Number: IC71132UG
• Device Lot Number: 30526888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 08/08/2022; 08/11/2022
• Supplement Dates FDA Received: 08/08/2022; 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 132CM LARGE BORE 71 CATHETER.; 6FR FLEXOR® SHUTTLE® GUIDING SHEATH (COOK MEDICAL).; ACE¿ 60 REPERFUSION CATHETER (PENUMBRA).; EMBOTRAP III 5 MM X 37 MM.; REBAR¿ 18 MICROCATHETER (MEDTRONIC).; SYNCHRO2¿ STANDARD GUIDEWIRE (STRYKER).