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

Model Number	82-3074
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Cerebral Ventriculomegaly (2133); Confusion/ Disorientation (2553)
Date of Event	07/01/2022
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
This is 2 of 2 reports linked to mfg report number: 3013886523-2022-00412.A physician reported a certas valve (id 828804) was implanted via l-p shunt on (b)(6) 2022, with setting 3.It was used with bactiseal peritoneal catheter (id 823074).After 1 week of implantation, the patient had a tendency for ventriculomegaly and presented with disorientation.An mri was performed, and the flow could not be confirmed on the ventral side.The valve and the peritoneal catheter were removed and replaced on (b)(6) 2022.Patient recovery was observed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10.The bactiseal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected; 470mm of catheter was returned no defects noted.The catheter was flushed no occlusion noted.The catheter was leak tested no leaks noted.No root cause could be determined as the technician could not confirm any problems with the catheter at the time of investigation.The possible root cause for the issue reported by the customer could be due to an issue with the valve.

• 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: 15379312
• Report Number: 3013886523-2022-00413
• Device Sequence Number: 12189322
• 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 Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 82-3074
• 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): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/05/2022
• 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 Age: 60 YR
• Patient Sex: Male