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

Model Number	82-3073
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
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2022-00533 and 3013886523-2022-00535.A facility reported a certas valve (id 828814) was implanted via v-p shunt on november 2021 with unknown setting.It was used with a bactiseal ventricular catheter (id 823073 serial: unk) and a bactiseal peritoneal catheter (id 823074 serial: unk).In the beginning of (b)(6) 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 ventricular catheter (id 823073) was returned for evaluation.Failure analysis - the catheters were visually inspected; no defect was noted.The catheters were irrigated: no occlusion was noted.The catheters were leak tested, no leak was noted.No root cause could be determined for the issue reported by the customer as no occlusions were found with the catheter.The possible root cause for the issue reported by the customer could have been to biological debris and protein build up interfering with the catheter, but at the time of investigation no enlargement issues were noted.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Common Device Name: BACTISEAL VENTRICULAR 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: 15749893
• Report Number: 3013886523-2022-00534
• Device Sequence Number: 6225540
• Product Code: JXG
• UDI-Device Identifier: 10886704041320
• UDI-Public: 10886704041320
• 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): 02/03/2023

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: 82-3073
• Device Catalogue Number: 823073
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 02/03/2023
• 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