MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROGRAMMABLE VALVE INLINE UNTZ; CHPV

Model Number	82-3844
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	09/22/2022
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 facility reported a hakim valve (id 823844) was implanted via v-p shunt on (b)(6) 2019 with unknown setting.The patient had ventricular enlargement; therefore, the valve was removed and replaced on (b)(6) 2022.According to physician, the cause of ventricular enlargement is unknown, however, it was believed that this event was possibly happened by obstruction or kink of catheter.
Additional Manufacturer Narrative
The hakim valve (id 823844 was returned for evaluation.Device history record (dhr) - the product code 82-3844 with lot 194598, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 120 mmh2o.The valve was visually inspected; the proximal connector was missing, a tear/cut was noted between the missing connector and the needle chamber.The valve was hydrated.The catheters were irrigated no occlusions noted.The catheters were leak tested no leaks noted.The valve was leak tested and leak from the cut/tear in the silicone housing.The valve passed the test for programming, occlusion, reflux and pressure.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve, at the time of investigation no enlargement issues were noted.The possible root cause for the ¿cut/tear¿ due a sharp or pointed object coming into contact with the valve, as noted in ifu, silicone has a low cut/tear resistance.

• Brand Name: PROGRAMMABLE VALVE INLINE UNTZ
• Common Device Name: CHPV
• 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: 15717362
• Report Number: 3013886523-2022-00504
• Device Sequence Number: 12412459
• Product Code: JXG
• UDI-Device Identifier: 10886704041863
• UDI-Public: (01)10886704041863(17)230430(10)194598
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/06/2023

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 Expiration Date: 04/30/2023
• Device Model Number: 82-3844
• Device Catalogue Number: 823844
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2018
• 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: 43 YR
• Patient Sex: Female