MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number	823162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2023
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 823162) was implanted via ventriculoperitoneal (v-p) shunt on (b)(6) 2022 with unknown setting.On (b)(6) 2022, an attempt was made to change the set pressure from 70 to 50mmh2o, but it was not possible, and it could not be changed even with neodymium.The patient was well and was followed up.On (b)(6) 2023, shunt angiography was performed, and the flow was confirmed on both the ventricular and abdominal sides, however, improvement in the ventricle was not observed.Due to suspicion of valve obstruction, the valve was removed and replaced on (b)(6) 2023.According to the physician's comment, when the catheter on the ventricular side was pulled out, cerebrospinal fluid came out of the ventricular catheter, so obstruction at the valve was suspected.The patient recovered.
Additional Manufacturer Narrative
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr)- the product code 82-3162 with lot 4959988, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected, a needle hole in the needle chamber was noted.The position of the cam when valve was received was 80mmh2o.The valve was leak tested, only leaked from the needle hole in the needle chamber.The valve was hydrated.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.Root cause analysis - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any problems with the valve at the time of investigation.A possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism.As seen in the investigation report no functional issues were noted.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• 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: 17210325
• Report Number: 3013886523-2023-00196
• Device Sequence Number: 6741224
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)250831(10)4959988
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 08/10/2023

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: 08/31/2025
• Device Catalogue Number: 823162
• Device Lot Number: 4959988
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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: 17 MO
• Patient Sex: Male