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

Catalog Number	IC71125CA
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3: 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.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
A healthcare professional reported that during a thrombectomy, a long sheath (non-j&j brand), an embovac thrombus aspiration catheter (ic71125ca, 31434333), a non-j&j microcatheter (mc) and a non-j&j micro-guidewire were delivered in patient coaxially.The long sheath and thrombus aspiration catheter were impeded in the c2 segment of internal carotid artery and unable to advance to the target site.The doctor only removed the thrombus aspiration catheter, microcatheter and micro-guidewire from the patient for inspection.The thrombus aspiration catheter shaft was found kinked/bent.The doctor switched to a new thrombus aspiration catheter to complete the surgery with the same microcatheter and micro-guidewire.There was no patient injury reported.Additional event information received on 13-jun-2025 indicated that the event did not result in any undue procedural delay that could be considered clinically significant.The event did not result in patient harm.The target vessel/site being treated was the middle cerebral artery.There was no break in material integrity at the site of the defect, such as cracking or fracture.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h11.Correction: h6.Medical device problem code: deformation due to compressive stree (a040601).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).This complaint was reassessed on 19-aug-2025 and it was determined the new reportable pec, ¿damaged/deformed -in patient during thrombectomy,¿ does not apply to this complaint.In this case, the device had not reached the target position, which defines the start of the thrombectomy procedure.The pec: kinked/bent -in patient is being applied to this complaint.Catheter kinking/damage during clinical use is a known and common occurrence occurring during angiography and is typically related to anatomy, technique, skill, and vessel tortuosity.The instructions for use cautions users to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.If the operator encounters kinking or damage during use, they are clinically trained to immediately discontinue manipulations and remove the product.Therefore, the potential for patient injury/death occurring as a result of kinking or bend type damage is remote.Therefore, this event is being un-reported.

• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22395421
• Report Number: 3008114965-2025-00670
• Device Sequence Number: 15750810
• Product Code: NRY
• UDI-Device Identifier: 10886704082361
• UDI-Public: (01)10886704082361(17)260131(10)31434333
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/20/2025

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: 01/31/2026
• Device Catalogue Number: IC71125CA
• Device Lot Number: 31434333
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/12/2025; 08/19/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/09/2025; 08/18/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LONG SHEATH (UNSPECIFIED BRAND); MICROCATHETER (UNSPECIFIED BRAND); MICROCATHETER (UNSPECIFIED BRAND); MICROGUIDEWIRE (UNSPECIFIED BRAND)
• Patient Sex: Unknown