MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV RT ANG RES W SG UNITIZED; CHPV WITH SG

Model Number	82-3146
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Cerebral Ventriculomegaly (2133)
Date of Event	12/29/2021
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 hakim valve (id (b)(4)) as implanted via v-p shunt in (b)(4) 2021 with setting 110mmh2o.On (b)(6) 2021, the patient had a headache and an x-ray was performed.Ventricular enlargement was confirmed, so the valve set pressure was lowered to 50 mmh2o, but the ventricles did not shrink.On (b)(4) 2021 a shunt contrast was performed and the valve system was suspected to be obstructed; therefore, on (b)(6) 2021, the valve system was removed and replaced.The patient recovered.
Additional Manufacturer Narrative
The hakim valve (id (b)(6) was returned for evaluation.Failure analysis - the valve was visually inspected; a needle hole in the underside of the valve casing was noted.The position of the cam when valve was received was 40mmh2o.The valve was hydrated.The catheters were irrigated no occlusions noted.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The valve functions.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the problem reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no functional issues were noted.
Event or Problem Description
N/a.

• Brand Name: CHPV RT ANG RES W SG UNITIZED
• Common Device Name: CHPV WITH SG
• 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: 13308157
• Report Number: 3013886523-2022-00009
• Device Sequence Number: 4964790
• Product Code: JXG
• UDI-Device Identifier: 10886704041535
• UDI-Public: (01)10886704041535(17)240731(10)3977403
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 03/16/2022

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 Expiration Date: 07/31/2024
• Device Model Number: 82-3146
• Device Catalogue Number: 823146
• 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: 01/03/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• 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: 72 YR
• Patient Sex: Female