MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN; BACTISEAL CATHETER KIT

Catalog Number XXX- BACTISEAL CATHETER

Device Problem Break (1069)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Event Description

1 of 2 reports.Other mfg report number: 3013886523-2024-00079.A facility reported a patient presented with hydrocephalus symptoms.A x-ray was taken on (b)(6) 2024 showing a broken catheter.The catheter and the hakim valve were explanted due to broken catheter.The valve was implanted in 2018 and the catheter in 2010.

Manufacturer Narrative

Catheter was not returned for evaluation (discarded by customer) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.X ray's were provided by the customer and confirmed the break in the catheter.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNKNOWN
• Type of Device: BACTISEAL CATHETER KIT
• 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 ; 6099362319
• MDR Report Key: 18945353
• MDR Text Key: 338187007
• Report Number: 3013886523-2024-00078
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- BACTISEAL CATHETER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1