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

Catalog Number	GS9095SD
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that damage was noted upon opening in the two 95cm cerebase da guide sheath (gs9095sd) from the same lot number (31347438).There was no negative patient impact.On 08-aug-2024, additional information was received.Per the information, the distal tip was damaged on both cerebase devices.The reported issue did not result in any delay in the procedure.There was no difficulty in removing the devices from their respective packaging.There was no damage noted on the packaging of the devices.The devices were returned for evaluation and analysis.Based on the result of the product analyses completed on 29-nov-2024, one of the cerebase was noted to have a fracture but was not completely separated.The observed finding meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".
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: the initial reporter email address was not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 95cm cerebase da guide sheath was received folded and contained in the decontamination pouch.Visual inspection was performed.A fracture was noted at 49 cm from the distal end.The device was still connected by the internal braided wires.Additionally, a compressed section measuring 4 cm was noted at the distal portion of the device.The distal tip was found in a 90-degree shape.Microscopic inspection was performed.Under magnification, it was observed that due to the severity of the compress the internal wires were exposed on the distal portion.The inner diameter (id) and outer diameter (od) of the device were confirmed to be within specifications.The reported issue documented in the complaint related to the catheter being damaged was confirmed based on the appearance of the returned device.The observed damaged conditions could be the result of several factors, including but not limited to procedural factors present in the operating room.However, with the limited information available, an assignment of a root cause is not possible at this time.The compression at the distal tip portion is suspected to be a result of device handling and manipulation where excessive force may had been applied to the device.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.According to the risk documentation, a catheter shaft being kinked is a potential issue that can occur due to an improper handling of the device when is removed from the pouch.The separation found on the shaft was not originally reported in the complaint and is suggested to have appeared during the post-operational handling of the device and is not considered related to the reported issue.A review of manufacturing documentation associated with this lot (31347438) 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 was identified as scrap and properly accounted for.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent catheter damage from leaving the facility.It should be noted that product failure is multifactorial.The instruction for use (ifu) contains the following precaution: do not use a catheter that has been damaged in any way.If damage is detected, replace it with another catheter that is not damaged.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.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: 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 ; 303552-6892
• MDR Report Key: 20827498
• Report Number: 3008114965-2024-01172
• Device Sequence Number: 9474336
• Product Code: QJP
• UDI-Device Identifier: 10886704082323
• UDI-Public: (01)10886704082323(11)240523(17)260731(10)31347438
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 07/31/2026
• Device Catalogue Number: GS9095SD
• Device Lot Number: 31347438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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