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

Catalog Number IC71132CA

Device Problems Material Separation (1562); Stretched (1601); Material Twisted/Bent (2981)

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

Event Date 04/07/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, and weight, were not provided.Section e.1: the initial reporter phone: 0749-45-5000.The initial reporter email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30729955) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 report is being submitted pursuant to the provisions of 21 cfr, part 803.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.

Event Description

The healthcare professional reported that during a mechanical thrombectomy procedure targeting an occlusion in the left middle cerebral artery (mca), an embovac large bore catheter (ic71132ca / 30729955) and embotrap revascularization device (catalog and lot number unknown) were used concurrently.After two passes with the embovac and embotrap device, the embovac was pulled out.The embovac got damaged at about 10 cm from the tip.It had been stretched and bent.A new embovac device was used.After four (4) passes, recanalization was confirmed and the procedure was completed.There was no negative patient impact reported.On 07-may-2023, additional information was received.The information confirmed the lot number of the embovac was 30729955.The information also confirmed there was no patient injury or adverse event reported.Continuous flush was maintained through the trevo trak 21 microcatheter (stryker).On 30-may-2023, additional information was received.The information indicated that the procedure employed the combined technique with the embotrap iii device.There was no vessel calcification, only minor tortuosity.The information indicated that there was a break in the embovac device at the site of the defect leading to a separation in to two or more separate pieces.Based on the additional information received on 30-may-2023, the event has been deemed reportable as a "malfunction.".

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 26-jun-2023.[additional information]: on 26-jun-2023, additional information was received.The information indicated that the lot number of the embotrap device could not be obtained.There was no device performance issue related to the embotrap device during the procedure.There was no report of any difficulty deploying the embotrap device; it was the same embotrap device used with the replacement embovac to complete the procedure.A total of four (4) passes were made with the embotrap device.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17140371
• MDR Text Key: 317306498
• Report Number: 3008114965-2023-00347
• 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
• Report Date: 06/27/2023

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: 07/31/2023
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30729955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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: TREVO TRAK 21 MICROCATHETER (STRYKER); UNK_THROMBECTOMY NEURAVI
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian