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

Model Number	823074
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports.Other mfg report number: 3013886523-2023-00077.A physician reported a certas valve (id 828800) was implanted in (b)(6) 2022 due subarachnoid hemorrhage via lumbar peritoneal shunt with setting 3.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj) and with peritoneal cather ( id 823074).On (b)(6) 2023, the setting was changed from 3 to 2 because the ventricles did not shrink.On (b)(6) 2023, an x-ray was taken, however, the ventricles still did not shrink, so setting 2 was changed to 1.On (b)(6) 2023, the shunt system was removed and replaced because the ventricle still did not shrink even in setting 1.The patient had gait disturbance.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The bactiseal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected; near to where the catheter is tied to the valve cuts/holes were noted.The catheter was irrigated, no occlusion noted.The catheter was leak tested failed leaked from the cuts/holes in the catheter.The root cause for the issue reported by the customer is probably due to the cut/tears in the catheter, causing leakage of "csf" into unintended parts.The root cause for the cut/tear in the catheter is due to a sharp or pointed object coming into contact with the catheter, as noted in the "ifu" silicone has a low cut/tear resistance.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: 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: 16592550
• Report Number: 3013886523-2023-00079
• Device Sequence Number: 14208566
• Product Code: JXG
• UDI-Device Identifier: 10381780515630
• UDI-Public: 10381780515630
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 823074
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male