MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 125 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number IC71125CA

Device Problems Crack (1135); Stretched (1601); Material Deformation (2976)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during three different cases, there were problems such as elongation at the tip of the catheter, stretching, creeping, crushing, breaking behind the catheter hub, and breaking of the catheter were observed in five different 125cm ic 71 embovac aspiration catheters (ic71125ca) on the same day.This complaint is related to a 125cm ic 71 embovac aspiration catheter (ic71125ca / 31041009).It was reported that aspiration and co-aspiration methods were attempted.The cerebase da was used with a long sheath.It was reported that ¿transactions take 10 minutes.There has been a delay (duration unspecified).¿ the patient is reported to be in good condition; there was no report of any negative patient impact.A photo was included in the complaint file.

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 initial reporter phone is 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.The product analysis team reviewed the photo included in the complaint.The review is documented below.[photo review]: one (1) photo accompanied the complaint file in which the proximal end of the catheter was shown.It was noted that the hub is separated just next to the id band.The rest of the device cannot be evaluated.A review of manufacturing documentation associated with this lot (31041009) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The issue reported regarding the breaking behind the catheter hub was confirmed based on the condition seen in the picture.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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.

• Brand Name: IC 71, 125 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 ; 303552-689
• MDR Report Key: 18924632
• MDR Text Key: 337913398
• Report Number: 3008114965-2024-00275
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K191237
• 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
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71125CA
• Device Lot Number: 31041009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2023
• 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: CEREBASE LONG SHEATH