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	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
2 of 2 reports.Other mfg report number: 3013886523-2023-00317.A facility reported a certas valve (id (b)(6)) was implanted via l-p shunt on unknown date with unknown setting.The valve was used with silascon lumbar catheter (manufactured by kaneka, product code: 702-jj), and bactiseal peritoneal catheter (id (b)(6)) (serial: unk).The shunt system was suspected to be occluded, therefore, the patient had revision surgery.According to information provided it is unknown if the catheter was obstructed; however it was removed.It is also unknown if the patient experienced signs and symptoms of obstruction.
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 catheter (id ns0339) was returned for evaluation.Failure analysis - the catheter was visually inspected, no defects were noted.The catheter was irrigated and no occlusion noted.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.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the catheter, at the time of investigation no function issues were noted.
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 ; 6099362319
• MDR Report Key: 17744457
• Report Number: 3013886523-2023-00318
• Device Sequence Number: 4145711
• 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?: Yes
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/14/2023
• 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