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

Model Number	82-3074
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Fistula (1862)
Date of Event	10/28/2022
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
Reports linked to mfg report numbers: 3013886523-2022-00533, 3013886523-2022-00534.A facility reported a certas valve (id 828814) was implanted via v-p shunt on (b)(6) 2021 with unknown setting.It was used with a bactiseal ventricular catheter (id 823073 serial;unk) and a bactiseal peritoneal catheter (id 823074serial;unk).In the beginning of october, the skin at the site where the valve was placed was thinning, and a fistula of about 2 mm was formed, through which cerebrospinal fluid leaked.On (b)(6) 2022 when the valve was removed, damage to the silicone near the sg was confirmed.The bactiseal ventricular catheter and the bactiseal peritoneal catheter were also removed on (b)(6) 2022.After shunt removal, there is a tendency for ventricular enlargement.The valve was not replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id (b)(4), serial;unk) was returned for evaluation.Failure analysis - the catheter was 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 and protein build up interfering with the catheter, at the time of investigation the no functional issues were noted with the catheter.

• 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: 15749891
• Report Number: 3013886523-2022-00535
• Device Sequence Number: 12318469
• 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: 2021
• Device Explanted Year: 2022
• 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): 02/14/2023

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 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): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 02/14/2023
• 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: Female