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 Injury (2348)

Event Date 12/15/2020

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: 3013886523-2020-00299.A physician reported a certas plus small valve and bactiseal catheters were implanted on a 4-month female patient on (b)(6) 2020 for the treatment of hydrocephalus.On (b)(6) 2020, the patient had to be taken back to surgery for a shunt revision because the patients¿ symptoms of increased head circumference and bulging fontanel.Patient condition was decreasing prior to surgery for revision.The certas plus small valve only was replaced by another certas plus small valve only (828810pl lot# 4940607) and the bactiseal peritoneal catheter was replaced by a bactiseal barium stripe distal catheter (ns0339 lot# 4963361).

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The catheter was returned for evaluation: device history record - lot 4384768, conformed to the specifications when released to stock failure analysis- the catheter was visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.The catheter was leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for the issue reported by the customer could be due biological debris and protein buildup interfering with the device at the time of investigation, no occlusion issues were noted.

Event Description

N/a.

• 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
• MDR Report Key: 11120863
• MDR Text Key: 225281122
• Report Number: 3013886523-2020-00300
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 823074
• Device Lot Number: 4384768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 MO