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

Model Number	82-3074
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	03/17/2022
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 numbers: 3013886523-2022-00139.A physician reported a certas valve was implanted in a (b)(6) female patient due to sah (subarachnoid hemorrhage) via l-p shunt on (b)(6) 2022 with setting 3.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj) and bactiseal peritoneal catheter (id 823074-serial;unk).On march 11, the patient had disorientation.The pressure setting was changed with etk for fluoroscopy (3 to 2).On march, 17, the patient had disorientation.A shunt contrast was performed, but no obstruction was observed.On march 18, no improvement in symptoms was seen, the valve and peritoneal catheter were removed and replaced on (b)(6) 2022.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10 the peritoneal catheter (id 823074) was returned for evaluation.Failure analysis - the catheters were visually inspected; no defects were noted.The catheter was irrigated no occlusions noted.The catheter was leak tested no leaks noted.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 interfering with the device, at the time of investigation no functional issues were noted.

• 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: 14021990
• Report Number: 3013886523-2022-00140
• Device Sequence Number: 14957419
• 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): 06/02/2022

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: 03/22/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 06/02/2022
• 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: 76 YR
• Patient Sex: Female