MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A facility reported a bactiseal peritoneal catheter was implanted via ventriculo-peritoneal shunt a few years ago.There was a suspicion of obstruction, therefore, the catheter was explanted and replaced on (b)(6) 2024.It was replaced with catalogue # ns0339.The patient's condition is currently stable.The bactiseal peritoneal catheter was used with bactiseal ventricular catheter (id (b)(6) and certas valve (b)(6); however only the peritoneal catheter was explanted and replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheters were irrigated, no occlusions noted.The catheter was leak tested; no leaks were noted.The complaint was unconfirmed.Root cause analysis - no root cause could be determined as the technician could not confirm any problem with the catheter at the time of investigation.A possible root cause for the ¿obstruction;¿ issue reported by the customer could be due to biological debris occluding the catheter or a kink in the catheter.At the time of investigation, no obstruction issue was noted.

• Brand Name: BACTISEAL PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19234556
• Report Number: 3013886523-2024-00132
• Device Sequence Number: 6883188
• Product Code: JXG
• UDI-Device Identifier: 10886704041337
• UDI-Public: 10886704041337
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL VENTRICULAR CATHETER (B)(6).; CRTS SM IL SG VLV ONLY (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown