MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER

Catalog Number 823074

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2021

Event Type  Injury  

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 Description

2 of 2 reports.Other mfg report number: 3013886523-2021-00402.A physician reported a certas plus valve (id 828814 ) and a bactiseal peritoneal catheter (id 823074) were implanted to a patient via ventricular peritoneal shunt on an unknown date with an unknown setting.The set pressure could not be changed and valve obstruction was suspected.The patient had a head injury that caused a fracture in the skull near the valve and there was also suspicion that the valve was damaged.The valve and catheter were removed and replaced on (b)(6) 2021.

Manufacturer Narrative

The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Unique device identification (udi): (b)(4).Failure analysis - the complaint device was retuned with the valve (mfg report number 3013886523-2021-00402).The position of the cam when valve was received was at setting 2.The valve was visually inspected; needle holes in the needle chamber were noted and marks in the proximal connector were also noted.The valve was hydrate.The catheter was irrigated, no occlusions noted.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the catheter, at the time of investigation the no occlusion issues were noted with the catheter.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Type of Device: BACTISEAL PERITONEAL CATHETER
• 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: 12523920
• MDR Text Key: 273096077
• Report Number: 3013886523-2021-00403
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 17 MO