MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM ATRIAL CATH, 46CM; STANDARD CATHETERS

Catalog Number	823044
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	09/12/2024
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 hakim atrial catheter was implanted due to unknown reason via va (ventriculoatrial) shunt with unknown setting in 2020.The patient had ambulation difficulty.A contrast radiography was performed and confirmed a csf leakage from the catheter; therefore, the catheter was explanted and replaced with a new one on (b)(6) 2024.However, no leak from the catheter was observed after it was explanted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim atrial catheter (id 823044) was returned for evaluation.Failure analysis - the catheter was visually inspected; the received catheter was only 315mm - no defects noted.The ends of the catheter were visually inspected and seemed to be clean cut.The catheter was irrigated and leak tested, no occlusion and leaks were noted.The complaint was unconfirmed.Root cause analysis - no root cause could be determined.As noted in the investigation, no leakage was noted with the returned 315mm catheter.The possible root cause for the issue reported by the customer could not be clearly determined as only 315mm of catheter was returned but could be linked to a sharp or pointed object coming into contact with the device.As noted in the ifu, silicone has a low cut/tear resistance.

• Brand Name: HAKIM ATRIAL CATH, 46CM
• Common Device Name: STANDARD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20369189
• Report Number: 3013886523-2024-00311
• Device Sequence Number: 17859795
• Product Code: JXG
• UDI-Device Identifier: 10381780518822
• UDI-Public: 10381780518822
• Combination Product (Y/N): N
• PMA/510(K) Number: K944222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 823044
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 70 YR
• Patient Sex: Female