MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM EMBOVAC 71 ASP. CATHETER; EMBOVAC ASPIRATION CATHETER

Catalog Number IC71132CA

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Stretched (1601)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a thrombectomy procedure for an acute ischemic stroke (ais) with the target occlusion in the m1 segment, after preparation in accordance with the instructions for use (ifu), a 132cm embovac 71 aspiration catheter (ic71132ca / 30582686) and a 5mm x 37mm embotrap iii revascularization device (et309537 / 21l196av) were used.The embovac was elevated only to the front of the siphon, because of the patient¿s blood vessels are strongly flexion, the embotrap was deployed and raised the embovac as anchor.There was no problem, but when the physician tried to withdraw it while applying suction, there was resistance.Continuous flush was maintained.When the products were collected while experiencing the resistance, the embovac stretched and water leakage was confirmed from the stretched area during flushing.The suction catheter was changed and it was removed without incident with the embotrap device.The procedure was completed.The complaint devices are reported to be available to be returned.Preliminary photo images of the 132cm embovac 71 aspiration catheter were captured by the j&j japan affiliates and included in the complaint file on (b)(6) 2022.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.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.Investigation findings / investigation conclusions: the ¿no findings available¿ code was used in the investigational findings because the actual complaint device has not been received.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.[photo analysis]: preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file.The photos underwent review by the product analysis lab as documented below.Pre-shipment photos were provided.It can be observed that the braid mesh section is compressed and stretched in two locations.Microscopic examination of the stretched portions revealed that the coating was worn out.The catheter shaft was also noted to be slightly compressed in one location.This damage was not noted within the event description and the time when it occurred could not be determined.The distal tip was circle-shaped, no damage could be noted on it.The customer complaint as related to the embovac being stretched was confirmed based on the photos.Although the customer complaint in relation to the water leakage could not be confirmed, the damages observed on the braid mesh coating could have contributed to this failure.Similarly, these damages could be secondary to the withdrawal difficulty experienced during the procedure.A review of manufacturing documentation associated with this lot (30582686) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturing record evaluation was performed.There is no indication that the failure reported is related to the manufacturing process.Further investigation will be performed once the device is returned for analysis.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2022-00028.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 the product analysis lab on 12-apr-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00184 and 3011370111-2022-00028.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 include the additional event information received on 25-apr-2022.[additional information]: on 25-apr-2022, additional information was received.The information indicated that the patient¿s blood vessels have strong flexion.The embovac device was removed intact from the patient.There was no break in the device integrity (metal, nitinol, or wire).The procedure was completed using the same 5mm x 37mm embotrap iii revascularization device (et309537 / 21l196av); the embovac suction catheter was changed and it was removed without incident with the embotrap iii device.There was no evidence of thromboembolism due to the withdrawal difficulty.The embotrap iii device did appear damaged in anyway.E1: initial reporter phone: (b)(4).This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00184 and 3011370111-2022-00028.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 make a correction to the supplemental follow-up medwatch #2.[correction]: the additional information received on 25-apr-2022 stated that the embotrap iii device did not appear damaged in any way.This was incorrectly documented as ¿the embotrap iii device did appear damaged in anyway.¿ in the supplemental follow-up #2 medwatch report.Updated sections: b.4, g.3, g.6, h.2, h.10, and h.11.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2022-00028.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.This was incorrectly documented as ¿the embotrap iii device did appear damaged in anyway.¿ in the supplemental follow-up #2 medwatch report.

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 for an acute ischemic stroke (ais) with the target occlusion in the m1 segment, after preparation in accordance with the instructions for use (ifu), a 132cm embovac 71 aspiration catheter (ic71132ca / 30582686) and a 5mm x 37mm embotrap iii revascularization device (et309537 / 21l196av) were used.The embovac was elevated only to the front of the siphon, because of the patient¿s blood vessels are strongly flexion, the embotrap was deployed and raised the embovac as anchor.There was no problem, but when the physician tried to withdraw it while applying suction, there was resistance.Continuous flush was maintained.When the products were collected while experiencing the resistance, the embovac stretched and water leakage was confirmed from the stretched area during flushing.The suction catheter was changed and it was removed without incident with the embotrap device.The procedure was completed.The complaint devices are reported to be available to be returned.Preliminary photo images of the 132cm embovac 71 aspiration catheter were captured by the j&j japan affiliates and included in the complaint file on 25-mar-2022.[photo analysis]: preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint file.The photos underwent review by the product analysis lab as documented below.Based on the photos provided, it can be observed that the braid mesh section is compressed and stretched in two locations.Microscopic examination of the stretched portions revealed that the coating was worn out.The catheter shaft was also noted to be slightly compressed in one location.This damage was not noted within the event description and the time when it occurred could not be determined.The distal tip was circle-shaped, no damage could be noted on it.The customer complaint as related to the embovac being stretched was confirmed based on the photos.Although the customer complaint in relation to the water leakage could not be confirmed, the damages observed on the braid mesh coating could have contributed to this failure.Similarly, these damages could be secondary to the withdrawal difficulty experienced during the procedure.A review of manufacturing documentation associated with this lot (30582686) 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.The manufacturing record evaluation was performed.There is no indication that the failure reported is related to the manufacturing process.On 25-apr-2022, additional information was received.The information indicated that the patient¿s blood vessels have strong flexion.The embovac device was removed intact from the patient.There was no break in the device integrity (metal, nitinol, or wire).The procedure was completed using the same 5mm x 37mm embotrap iii revascularization device (et309537 / 21l196av); the embovac suction catheter was changed and it was removed without incident with the embotrap iii device.There was no evidence of thromboembolism due to the withdrawal difficulty.The embotrap iii device did not appear damaged in anyway.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 132cm embovac 71 aspiration catheter was received contained in a pouch.Visual inspection was performed.The presence of hydrophilic coating was confirmed.All the conditions observed in the photos provided were observed on the physical product and further evaluation is described below: the distal tip was confirmed to be circle-shaped; no damages or anomalies were observed on it.This indicates that there was no difficulty to advance the embovac catheter.The mesh section was observed in a stretched condition at 5.5 cm (2.165 in.), and at 6.5 cm (2.165 in.) through 8.5 cm (3.346 in.) from the distal end, further inspection under microscopic magnification revealed that as a result of the stretching, the mesh structure was exposed: the coating was observed torn.The catheter shaft was in a compressed condition at 16.5 cm (6.496 in.) from the distal end where fingertips seemed to be used to hold or retrieve the device.This reasonably suggests that the damages occurred during the retrieval of the distal part of the catheter.The catheter shaft was in a kinked condition at 76 cm (29.921 in.) from the distal end, this damage is not considered a contributing factor to the stretched condition reported and might have occurred during post-operative handling of the catheter as it was not observed on the preliminary photo images.The catheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).The reported issue documented in the complaint regarding the distal end of the embovac being stretched and leaking was confirmed based on the evidence observed on the braid mesh section.According to the information captured in the complaint ¿the embovac was stretched, and water leakage was confirmed from the stretched area during flushing.¿.The complaint also documented that the patient¿s blood vessels have strong flexion, which seems to be the most likely contributing factor to the withdrawal difficulty that ultimately resulted in the water leakage.There is no indication of any device defect that could be related to the issue reported.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use contain the following precaution: exercise care in handling the embovac 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00184 and 3011370111-2022-00028.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 EMBOVAC 71 ASP. CATHETER
• Type of Device: EMBOVAC 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: 13930797
• MDR Text Key: 298208181
• Report Number: 3008114965-2022-00184
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30582686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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: EMBOTRAP III 5 MM X 37 MM.; PHENOM¿ MICROCATHETER (MEDTRONIC).