MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL N/A; CATHETER, PERCUTANEOUS

Catalog Number	IC71125UG
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure on (b)(6) 2026, the physician opened the device packaging for the 125cm large bore catheter (lbc) 71 (ic71125ug / 31633650) for inspection.The tip of the lbc was found to be rough (not smooth with burrs as shown in the photo included in the complaint).The device was not used in the patient.A new device was used for the procedure.There was no negative impact on the patient.A photo was included in the complaint.The photo will be reviewed by the product analysis team.On 29-apr-2026, additional information was received.Per the information, the replacement device was another 125cm large bore catheter (lbc) 71 (ic71125ug).There was no procedure delay due to the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section e.1: initial reporter facility name: per new requirement from cac (cyberspace administration of china), in case complaint reporter¿s hospital is related to military, police department, military academy/institution, political party, government organ/agency or classified unit [1], the name of such employer should be desensitized and redacted prior to be transferred abroad.The account name and facility name were not allowed to be displayed in the relevant area.Section e.1: the initial reporter phone: (b)(6).Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.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 photo is attached to the complaint file.The photo captures the catheter tip with a kink no other damage was observed.The reported issue was not confirmed as no delamination was observed.However, the reported issue regarding the catheter being compressed was confirmed based on the compressed condition noted on the catheter.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.A review of manufacturing documentation associated with this lot (31633650) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.All product rejected during manufacturing were identified as scrap and properly accounted for.As part of the j&j medtech quality process, all devices are manufactured, inspected, and released to approved specifications.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.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: N/A
• Common Device Name: 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 949788-2078
• MDR Report Key: 25071837
• Report Number: 3008114965-2026-00607
• Device Sequence Number: 16054164
• Product Code: DQY
• UDI-Device Identifier: 10886704082361
• UDI-Public: (01)10886704082361(17)260930(10)31633650
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K191237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: IC71125UG
• Device Lot Number: 31633650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 06/12/2026; 06/19/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/12/2026; 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown