MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VENTRIC CATH BAR RA 4CM; STANDARD CATHETERS

Catalog Number	821654
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Vomiting (2144)
Date of Event	01/26/2025
Type of Reportable Event	Serious Injury
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
A facility reported a ventricular catheter (id 821654) was implanted on (b)(6) 2024.The patient presented to the emergency room with symptoms of intracranial hypertension (vomiting, fatigue and headaches).A brain scan was performed urgently, showing the disconnection of the proximal catheter from the valve and its migration into the intraparenchymal towards the brainstem.Therefore, the proximal catheter was removed and replaced.All pieces were recovered, and intraventricular bleeding was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The ventricular catheter was returned for evaluation: dhr - lot 7136147 sn n/a, conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected; the distal part of the proximal catheter was broken at 5mm.The catheter was irrigated, no occlusions noted.The catheter was leak tested, no leaks were noted.Root cause - the issue reported by the customer was confirmed.The root cause could be human misuse in view of the irregular edges of the distal part of the device, probably resulting from the catheter stretching out, generating the tear.As noted in the ifu, silicone has a low cut/tear resistance.

• Brand Name: VENTRIC CATH BAR RA 4CM
• Common Device Name: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21432799
• Report Number: 3013886523-2025-00042
• Device Sequence Number: 17320467
• Product Code: JXG
• UDI-Device Identifier: 10381780517900
• UDI-Public: (01)10381780517900(17)280331(10)7136147
• Combination Product (Y/N): N
• PMA/510(K) Number: K172022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 821654
• Device Lot Number: 7136147
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown