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

Model Number	82-3073
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
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
A physician reported a bactiseal ventricular catheter (id 823073) which was connected to a hakim valve (id 823162) had disconnected on (b)(6) 2022 after vp shunt.It is unknown how the issue was found.All parts of catheter were retrieved.The catheter was replaced and no health hazard was reported.
Additional Manufacturer Narrative
The ventricular catheter (id 823073) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.No root cause could be determined as the technician could not confirm any problem with the catheters at the time of investigation.The possible root cause for the issue reported by the customer could be due to user¿s error, possibly catheter not tightly tied to the valve, at the time of investigation no issues were noted with the catheter.
Event or Problem Description
N/a.

• 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: 14852317
• Report Number: 3013886523-2022-00294
• Device Sequence Number: 4640120
• 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
• 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): 08/31/2022

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: 82-3073
• 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): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/31/2022
• 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 Sex: Unknown