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

Catalog Number	GS9095SD
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
As reported by the field, the hub of a cerebase straight distal catheter (gs9095sd, 31395244) was broken.The device was not clinical used.The packaging looked normal, no damage of packaging visible.There was no difficulty removing the device from the packaging.
Additional Manufacturer Narrative
Manufacturer's ref.No: (b)(4).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, h3, h6 and h11.Complaint conclusion: as reported by the field, the hub of a cerebase straight distal catheter (gs9095sd, 31395244) was broken.The device was not clinical used.The packaging looked normal, no damage of packaging visible.There was no difficulty removing the device from the packaging.The device was returned to j&j medtech for further evaluation.A non-sterile gs 90, 95 cm, straight, distal was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and the device was found to be fractured at 2cm from the id band.However, no appearance of damages were observed on the hub.Further inspection was performed on the hub component, and no damages were found.The fracture was also inspected under a microscope and it was observed that the internal braid wire was exposed.Elongation marks were noted on both edges.The other joints in the distal region of the catheter were intact, without obvious separations.The fracture surfaces of the vestamid shaft show stretching and tearing of the shaft material at the edges of the fracture, indicating material elongation and tearing.The customer complaint regarding a hub being broken could not be confirmed since no damages were found during the device inspection.There may have been other factors that contributed to the failure encountered during the procedure that could not be replicated in the laboratory setting.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The catheter was received with a fracture of the vestamid shaft.This is a known failure mode of the catheter and can occur on a properly fused catheter.The observed condition could be the result of several factors, including but not limited to procedural factors present in the operating room such as operator¿s technique.However, this condition is not considered related to the reported issue.A manufacturing record evaluation was performed for the finished device 31395244 number, and no non-conformances related to the malfunction were identified.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.The instructions for use (ifu) contain the following caution: ¿ exercise care in handling the cerebase da guide sheath to reduce the chance of accidental damage.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: CEREBASE
• 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: 21218213
• Report Number: 3008114965-2025-00082
• Device Sequence Number: 19703044
• Product Code: QJP
• UDI-Device Identifier: 10886704082323
• UDI-Public: (01)10886704082323(17)260930(10)31395244
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192804
• 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,Followup,Followup
• Report Date (Section B): 04/09/2025

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: 09/30/2026
• Device Catalogue Number: GS9095SD
• Device Lot Number: 31395244
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 03/05/2025; 04/08/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/18/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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
• Patient Sex: Unknown