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

Model Number	82-3832
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve was implanted via v-p shunt on unknown date with unknown setting.The patient visited the hospital on (b)(6) 2022 and an mri examination was performed.The set pressure before mri imaging was 200 mmh2o, but when the set pressure was confirmed under fluoroscopy, the pressure changed to 30 mmh2o.Therefore, the pressure did not change even after changing the pressure and confirming it by fluoroscopy again.The pressure could not be changed even with neodymium.The valve was removed and replaced on (b)(6), 2022.
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
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - the product code 82-3832 with lot 3214681, conformed to the specifications when released to stock.Failure analysis - a lot of biological debris in the valve mechanism, a needle hole in the needle chamber and a cut/tear in the silicon housing along the siphon guard were noted.The siphon guard was separated from the valve.The valve was tested for programming and the cam mechanism did not move.The valve could not be leak tested due to the separated siphon guard.The valve could not be reflux tested due to the separated siphon guard.The silicon housing was cut after the valve casing.The cam mechanism was gently moved, and the valve was retested for programming: failed, the cam mechanism did not move.The valve was dismantled.The valve was visually inspected under microscope with the appropriate magnification: marks on the siphon guard and biological debris on the ruby ball, seat of ruby ball, spring, spring pillar, base plate and on the cam mechanism were noted.The cam magnets were controlled and passed.The root cause for the programing issue reported by the customer was due to biological debris and protein build up found on the ruby ball, seat of ruby ball, spring, spring pillar, base plate and on the cam mechanism.

• 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: 13792169
• Report Number: 3013886523-2022-00096
• Device Sequence Number: 19809930
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(17)230930(10)3214681
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/25/2022

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: 10/30/2023
• Device Model Number: 82-3832
• Device Catalogue Number: 823832
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2018
• 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 Sex: Unknown