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

Model Number 82-3074

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a bactiseal peritoneal catheter (id 823074) and a bactiseal ventricular catheter (id 823073 serial;unk) were implanted with a certas valve (828814) via v-p shunt on november 2021 with unknown setting.In (b)(6) 2022, since the peritoneal catheter was disconnected, only the peritoneal catheter was removed and replaced.

Manufacturer Narrative

The bactiseal peritoneal catheter (id 823074) was not returned for evaluation after three good faith attempts (gfes) were made, and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The root cause of the reported issue could not be determined.However, a possible root cause for the issue reported by the customer could be due to user uses an incompatible/ inappropriate technique and/or sharp object cuts silicon material.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: 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: 15749890
• MDR Text Key: 303225390
• Report Number: 3013886523-2022-00536
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704041337
• UDI-Public: 10886704041337
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 82-3074
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• 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: 60 YR
• Patient Sex: Female