MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL LARGE BORE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	IC71125CA
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Based on the visual analysis of the pictures received, a crack was noted.The findings meet us regulatory reporting criteria.The device was not returned; therefore, no further investigation can be performed.Two (2) photos accompanied the complaint file.In the first photo, the catheter can be seen inside the dispenser hoop and the shaft of the catheter next to the luer hub can be seen severely kinked.The second photo shows a close-up look to the kink condition, and the shaft can be seen nearly separated in two pieces due to the severity of the kink.No other damages are seen.A manufacturing record evaluation was performed for the finished device 31184039 number, and no non-conformances related to the malfunction were identified.A manufacturing record evaluation was performed for the finished device 31184039 number, and no non-conformances related to the malfunction were identified.The customer complaint was confirmed.This investigation was performed based only on the photos provided, and the availability has been cataloged as unknown; therefore, if additional information is received in the future, the investigation will be reopened and investigation will be perform as appropriate.As part of j&j medtech quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.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.
Event or Problem Description
As reported by the field, the embovac catheter (ic71125ca, (b)(4).) was already visibly bent below the hub in the packaging before the launch.The product was not used in the patient.Pictures of the device were received on (b)(4).2025 showing catheter cracked.

• Brand Name: LARGE BORE CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21240956
• Report Number: 3008114965-2025-00091
• Device Sequence Number: 8533201
• Product Code: NRY
• UDI-Device Identifier: 10886704082361
• UDI-Public: (01)10886704082361(17)250331(10)31184039
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: 03/31/2025
• Device Catalogue Number: IC71125CA
• Device Lot Number: 31184039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown