MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL BARIUM STRIPED PERIT; BACTISEAL PERITONEAL CATHETER

Catalog Number	NS0339
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported a bactiseal barium peritoneal catheter (id (b)(6)) was implanted due to secondary normal pressure hydrocephalus (snph) via lumboperitoneal (lp) shunt on (b)(6) 2024 with setting 2.The bactiseal catheter was used as a peritoneal catheter to connect a valve and a connector.After the valve and catheter were connected during a patency test, the chamber did not return to its original state.All the parts were disassembled due to the suspicion of a kink in a joint.Both the valve and catheter underwent individual checks for patency and were confirmed to have flow.After the devices were assembled, they were unable to confirm the flow again.On (b)(6) 2024, all he devices, except for the lumbar catheter, were removed and replaced.There was a surgical delay of more than 30 minutes during the procedure due to product problem.The patient primary disease is subarachnoid hemorrhage.
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 barium catheter (id ns0339) was returned for evaluation.Device history record (dhr): the product code ns0399 with lot 7332596, conformed to the specifications when released to stock.Failure analysis: the catheter pieces were visually inspected; all ends of the catheter pieces seem to be clean cut with no kinking in the catheter pieces were noted.The catheter pieces were irrigated; no occlusions were noted.This complaint is unconfirmed.Root cause analysis: no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any problems with the returned catheter parts at the time of investigation.A possible root cause for the issue reported by the customer could be due to a kink in the catheter when implanted.No flow issues were noted with the catheter parts at the time of investigation.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL BARIUM STRIPED PERIT
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19143545
• Report Number: 3013886523-2024-00111
• Device Sequence Number: 7335218
• Product Code: JXG
• UDI-Device Identifier: 10381780524069
• UDI-Public: (01)10381780524069(17)241130(10)7332596
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: NS0339
• Device Lot Number: 7332596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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: CERTAS VALVE (ID 828804)
• Patient Age: 64 YR
• Patient Sex: Female