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); Failure to Advance (2524)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.A review of manufacturing documentation associated with this lot (30526653) 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.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.

Event Description

The healthcare professional reported that during a thrombectomy procedure of an m1 large vessel occlusion (lvo), the 132cm large bore catheter 71 (lbc) (ic71132ug / 30526653) was used with the walrus balloon guide catheter (q¿apel) and the velocity® delivery microcatheter (penumbra).The distal section of the lbc aspiration catheter stretched when retracting clot after aspiration and corking had been achieved.The lbc aspiration catheter felt stuck and then stretched.The walrus balloon catheter then came more proximal as well.A one-pass successful outcome was achieved.The device was used and prepped as per the instruction for use (ifu); it was confirmed that the snaking was not used as an initial tracking technique.Additional intervention was not needed to remove the device from the patient.There was no break in device integrity.Adequate and continuous flush was maintained through the devices.There was no report of any patient adverse event or complication.Additional information was received on 24 august 2021 indicated that the withdrawal of the lbc aspiration catheter seem stuck within the clot or dragging on the walrus balloon catheter while pulling back.The information indicated that it was ¿unclear if the issue retracting was the lbc aspiration catheter or tolerance variance issue with the walrus balloon catheter.¿ based on the additional event information received on (b)(6) 2021, this event has been deemed reportable as a ¿malfunction.¿ on 01 september 2021, additional information was received via a conference call with treating physician.The information indicated that the physician¿s standard workflow is aspiration first (non-snaker).The standard set up is: walrus balloon guide catheter, lbc tracked over the velocity microcatheter with the fathom¿ steerable guidewire (boston scientific).The physician stated that he has done a few cases with this set up and had no issues.This current procedure is a standard thrombectomy case with afib fresh clot, femoral approach, not a lot of tortuosity.The lbc tracked easily into the clot and the physician ¿buried¿ the tip of the lbc into the clot (5-10mm), this is his standard approach.When the physician was ready to retract the corked clot, he noticed that there was significant resistance pulling the lbc.It was stated that the walrus balloon guide catheter was inflated when the physician started to pull the lbc.The physician continued to pull against the resistance and opened the rotating hemostasis valve (rhv) to pull the lbc out.Upon inspection of the lbc, he noticed that it was stretched.The physician does not think that the rhv was the cause; he thinks the lbc stretched inside the patient.The physician used a 60cc syringe to aspirate through the walrus balloon guide catheter once the tip of the lbc clears the tip of the walrus.It was also reported that only the lbc was collected and is available for return; the walrus balloon guide catheter was not collected.

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 of an m1 large vessel occlusion (lvo), the 132cm large bore catheter 71 (lbc) (ic71132ug / 30526653) was used with the walrus balloon guide catheter (q¿apel) and the velocity® delivery microcatheter (penumbra).The distal section of the lbc aspiration catheter stretched when retracting clot after aspiration and corking had been achieved.The lbc aspiration catheter felt stuck and then stretched.The walrus balloon catheter then came more proximal as well.A one-pass successful outcome was achieved.The device was used and prepped as per the instruction for use (ifu); it was confirmed that the snaking was not used as an initial tracking technique.Additional intervention was not needed to remove the device from the patient.There was no break in device integrity.Adequate and continuous flush was maintained through the devices.There was no report of any patient adverse event or complication.Additional information was received on 24 august 2021 indicated that the withdrawal of the lbc aspiration catheter seem stuck within the clot or dragging on the walrus balloon catheter while pulling back.The information indicated that it was ¿unclear if the issue retracting was the lbc aspiration catheter or tolerance variance issue with the walrus balloon catheter.¿ based on the additional event information received on 24 august 2021, this event has been deemed reportable as a ¿malfunction.¿ on 01 september 2021, additional information was received via a conference call with treating physician.The information indicated that the physician¿s standard workflow is aspiration first (non-snaker).The standard set up is: walrus balloon guide catheter, lbc tracked over the velocity microcatheter with the fathom¿ steerable guidewire (boston scientific).The physician stated that he has done a few cases with this set up and had no issues.This current procedure is a standard thrombectomy case with afib fresh clot, femoral approach, not a lot of tortuosity.The lbc tracked easily into the clot and the physician ¿buried¿ the tip of the lbc into the clot (5-10mm), this is his standard approach.When the physician was ready to retract the corked clot, he noticed that there was significant resistance pulling the lbc.It was stated that the walrus balloon guide catheter was inflated when the physician started to pull the lbc.The physician continued to pull against the resistance and opened the rotating hemostasis valve (rhv) to pull the lbc out.Upon inspection of the lbc, he noticed that it was stretched.The physician does not think that the rhv was the cause; he thinks the lbc stretched inside the patient.The physician used a 60cc syringe to aspirate through the walrus balloon guide catheter once the tip of the lbc clears the tip of the walrus.It was also reported that only the lbc was collected and is available for return; the walrus balloon guide catheter was not collected.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 132cm large bore catheter 71 (lbc) was received contained in a pouch.Visual inspection was performed.The device was observed with compressed areas at 44 inches and 46 inches from the proximal end.The braided mesh is compressed and stretched.No other damages nor anomalies were observed during the visual inspection.Dimensional evaluation: the inner diameter (id) and outer diameter (od) of the returned device were measured and confirmed to be within specifications.Hub id = 0.0715 inch; specification: 0.071 inch minimum.Distal id = 0.0715 inch; specification: 0.071 inch minimum.Actual microcatheter od = 0.0830 inch; specification: max.0.0837 inch / min.0.081 inch.A review of manufacturing documentation associated with this lot (30526653) 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint reported that during a standard thrombectomy case with afib fresh clot, femoral approach, with not a lot of tortuosity.The lbc tracked easily into the clot and the physician ¿buried¿ the tip of the lbc into the clot (5-10mm), when the physician was ready to retract the corked clot, he noticed that there was significant resistance pulling the lbc.He continued to pull against the resistance and opened the rotating hemostasis valve (rhv) to pull the lbc out.Upon inspection of the lbc, he noticed that it was stretched.The physician does not think that the rhv was the cause.Based on the observations made during the visual inspection, the lbc is compressed in two areas, one at 44 inches and the other at 46 inches from the proximal end.The braided mesh is stretched and compressed, the issue reported is confirmed.The exact cause of the compressed and stretched condition of the device cannot be conclusively determined.The reported issue of withdrawal difficulty due to the significant resistance encountered when the physician was ready to retract the corked clot could not be duplicated.The returned complaint device is compressed and in stretched condition, which may be related to or are a result of the resistance encountered during the attempt to withdraw the device with the corked clot.However, this cannot be conclusively determined.The device dimensions were measured and confirmed to be within specification.Based on the manufacture record review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure could be caused by multiple factors.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) contains the following precaution: ¿ exercise care in handling the large bore catheter to reduce the chance of accidental damage.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¿ code was used in investigation findings to indicate that the withdrawal difficulty issue reported could not be duplicated.The exact cause cannot be determined.The code ¿cause not established¿ was used in investigation conclusions is corresponding to the code ¿no device problem found¿ as related to these issues.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 is to update the product evaluation to include the investigation results from the research and development (r&d) team.The returned device was sent to the r&d team for further evaluation.The investigation results are documented below.Visual inspection was conducted on the returned device.The distal end of the unit was found to be flattened and stretched, this type of failure is consistent with ¿prolapse¿ damage, this is where the shaft of the catheter is folded onto its own and forms a loop, this type of damage is confirmed when there are two kinks that are spaced apart approximately 1 cm, also, it is common for this failure to have areas before and after the damage to be unstretched and not ovalized or flattened.This failure has been replicated in a lab setting, when the catheter prolapses, the user is unaware of the shaft being folded, as a result, the user will attempt to remove the catheter and will experience a significant amount of restriction onto the base catheter as he is retrieving the device.The force felt by the user is the prolapsed area being straightened out and flattened out.For the second area of the catheter that was analyzed, it was found that the distal area of the catheter was stretched at the beginning of the chronoprene area.The tip of the catheter was found to be round, therefore, rotating hemostasis valve (rhv) overtightening is not likely.It is possible that the base catheter could have trapped the softest area of the catheter against a vessel and could have caused the stretching upon retrieval.A review of manufacturing documentation associated with this lot (30526653) 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 cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacture record 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.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12465449
• MDR Text Key: 280832858
• Report Number: 3008114965-2021-00423
• 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: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• 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: 30526653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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: FATHOM¿ STEERABLE GUIDEWIRE (BOSTON SCIENTIFIC).; VELOCITY® DELIVERY MICROCATHETER (PENUMBRA).; WALRUS BALLOON CATHETER (Q¿APEL).