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

Catalog Number 823074

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported that bactiseal peritoneal catheter (823074) was implanted to a patient via l-p shunt in early (b)(6).The catheter was used with 828804 (serial# unknown) and the silascon¿ lumbar catheter (manufactured by kaneka, product code: 702-jj).On (b)(6) 2021, postoperative follow-up was performed and it was found that the catheter was torn.It was also suspected that the connection between the catheter and the valve was loose.It was reported that the patient had revision surgery to remove the catheter; however, explant date or further information was not provided by the facility.

Manufacturer Narrative

The catheter was returned for evaluation: failure analysis: the catheter was visually inspected; one end was clean cut and the other end was a bit jagged.The catheter was irrigated, no occlusions noted.The catheter was leak tested; no leaks noted.The root cause for the issue reported by the customer is probably as reported by the customer ¿on (b)(6), there was a report that the catheter was torn at the postoperative follow-up.The device will be removed.According to the doctor, it was suspected that the connection between the catheter and the valve was loose.".

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: 12013383
• MDR Text Key: 267245894
• Report Number: 3013886523-2021-00273
• 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,u
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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: 07/23/2021
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 828804; SILASCON® LUMBAR CATHETER, PRODUCT CODE: 702-JJ