MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR TRAUMACATH, 35CM; N/A

Catalog Number	INS8420
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that on insertion of a new external ventricular drainage (evd), the traumacath, 35cm (ins8420) was noted to have a crack in it.Patient impact was unknown, and there was surgical delay; however, the duration of the delay is unknown.Unfortunately after following up with the team and the site, no further information is available for this case as it occurred last year, and the hospital does not have any notes on the issue to refer to.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The traumacath, 35cm (ins8420) was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomaly was observed during its manufacturing, packaging, and inspection process that could be related to the reported condition.Failure analysis - the visual inspection of the returned product shows blood residues/debris (clots and stains) inside the catheter; therefore, the product had been used at the field.The upper part of the catheter (proximal to surgeon) was observed to have been torn off.The breakage was uneven giving the appearance of broken-off, not cut.The missing portion (about 0.5 inch) was not returned.The nominal measurement for the catheter length from the tip is 14 inches, but the returned catheter approximately measured 13 5/8inches (at the longest side of the tear).Further evaluation revealed that there was a tear just below the 7 cm mark (approx.2 ¾ inches from the distal tip) on the catheter, and at the end of the torn part there are stress marks that suggest the tube was pulled beyond its breaking point.Root cause - the complaint is confirmed via the inspection.Based on the torn condition of the catheter at two (2) different places, it is concluded that the catheter was submitted to excessive force at the field.No capa escalation is required since the condition observed on the returned product suggests that the catheter tubing was submitted to excessive force at the field.There are controls during the manufacturing process to prevent and detect the reported condition.Also, upon review of integra¿s complaint system from june 2024 to august 2025, no additional complaints related to the reported have been identified for catalog ins8420 traumacath, 35cm, and no complaint trend signal has been identified for this reported condition.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: TRAUMACATH, 35CM
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22385703
• Report Number: 2648988-2025-00025
• Device Sequence Number: 6979184
• Product Code: JXG
• UDI-Device Identifier: 10381780023890
• UDI-Public: 10381780023890
• Combination Product (Y/N): N
• PMA/510(K) Number: K972994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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 Catalogue Number: INS8420
• Device Lot Number: 7392864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown