MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 132 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number IC71132CA

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/06/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h.3: 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2024-00031.

Event Description

As reported by the field, during a mechanical thrombectomy for an ischemic stroke, an embotrap ii 5x33 revascularization device (et007533, lot unknown) detached inside the embovac catheter (ic71132ca, 31130239) while retrieving the clot.Then they removed the full assembly and removed the embotrap from the aspiration catheter.The surgery was delayed due to the reported event by 20 minutes.A competitor¿s product was used to aspirate.Fragments generated but were easily removed without additional intervention.Additional event information received on 30-apr-2024 indicated that there was no resistance between the embotrap and the embovac at the time of deploying but yes while retrieving theses, resistance was encountered.Only one pass was made when there was an attempt to retrieve the clot.The clot was noted as being calcified, approximately.13mm but only 3mm to 4mm clot came out in one pass.There was difficulty withdrawing the embotrap from the thrombus and difficulty withdrawing the embotrap back through the vessel.The 20-minute surgery delay was not clinically significant.

• Brand Name: IC 71, 132 CM, CE, ASP. IND.
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19213893
• MDR Text Key: 341591019
• Report Number: 3008114965-2024-00452
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Device Lot Number: 31130239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• 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 II 5X33 REVASC. DEV.
• Patient Weight: 78 KG