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

Model Number	82-3832
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/20/2022
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 patient was sent to hospital on (b)(6), 2021 after a car accident.On (b)(6), 2021, a hakim valve (id 823832) and a bactiseal catheter (id 823072) were implanted due to hydrocephalus.During a ct check on (b)(6) 2022, the physician found that the hakim valve was occluded.Then they conducted a revision procedure and changed with a new hakim valve (id 823832).The bactiseal catheter remained implanted.
Additional Manufacturer Narrative
The hakim valve (id: 823832) was returned for evaluation.Device history record (dhr) - product code 82-3832 with lot: 4610225, showed 1 nr-report: (b)(4) when released to stock.Failure analysis - the valve was visually inspected; no defect was noted.The position of the cam when valve was received was 30 mmh2o.The valve was hydrated.The valve was tested for programming and failed the test.The valve was flushed and failed the test an occlusion was noted.The valve could not be leak tested due to the occlusion.The valve could not be reflux tested due to the occlusion.The cam mechanism was gently moved.The valve was retested for programming and failed the test.The valve could not be pressure tested due to the occlusion.The valve was disassembled.The valve was visually inspected under microscope with the appropriate magnification: biological debris was noted on the ruby ball, on the cam mechanism and on the base plate.The valve passed the test for siphon guard.The root cause for the occlusion problem reported by the customer was due to biological debris was sticking the ruby ball to the seat of the ruby ball.The root cause for the programming issue noted during the investigation is due to biological debris found on the cam mechanism.
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: 13652808
• Report Number: 3013886523-2022-00071
• Device Sequence Number: 5801481
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(17)250331(10)4610225
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 03/31/2025
• Device Model Number: 82-3832
• Device Catalogue Number: 823832
• Device Lot Number: 4610225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2020
• 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 Sex: Unknown