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

Catalog Number	NS0339
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation (as per customer, product not available) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
2 of 2 reports.Other mfg report number: 3013886523-2023-00307.A physician reported a certas valve (id 828804) was implanted via ventricular-peritoneal (vp) shunt on unknown date with unknown setting.It was used with bactiseal peritoneal catheter (id ns0339).Since obstruction was suspected, the valve and the bactiseal peritoneal catheter were removed on (b)(6) 2023.According to information provided, it is unknown if the catheter failed, however, it was explanted.It is also unknown if the patient experienced signs and symptoms due to product problem.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The catheter (id ns0339) was returned for evaluation.Failure analysis: the catheter was visually inspected and no defects were noted.The catheter was too short to allow any investigation.Root cause analysis: the possible root cause for the issue reported by the customer, could be due to catheter susceptible to kinking which leads to occlusion or could be due to biological debris and protein build up interfering with the catheter.However, it was not possible to confirm and identify the root cause of this assumption as the product was too short for investigation.

• 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 ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; ch-2400; mansfield MA ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17730246
• Report Number: 3013886523-2023-00308
• Device Sequence Number: 17752481
• Product Code: JXG
• UDI-Device Identifier: 10381780524069
• UDI-Public: 10381780524069
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/26/2023

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 Catalogue Number: NS0339
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/26/2023
• 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: Unknown