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	Injury (2348)
Date of Event	08/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unique device identifier (udi) : (b)(4).The hakim programmable vave was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Cause(s) of the difficulty reported by the customer could not be determined.The possible root cause for the problem reported by the customer could be due to ¿blockage due to build-up of protein¿.
Event or Problem Description
A post-market clinical program reported ventriculoperitoneal shunt obstruction: the hakim valve was implanted on (b)(6) 2018.On (b)(6) 2018 the patient returned to the hospital and the parents stated the patient had been crying for nearly 5 days.The patient was diagnosed with a ventriculoperitoneal shunt obstruction at the ventricular end.On (b)(6) 2018 the patient had a ventriculoscopy, cerebrospinal fluid drainage and removal of the right ventriculoperitoneal shunt was performed.The patient was discharged from the hospital on (b)(6) 2018 and was noted to be healing well.

• 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
• MDR Report Key: 10270238
• Report Number: 1226348-2020-00394
• Device Sequence Number: 804118
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 82-3832
• Device Catalogue Number: 823832
• Device Lot Number: 197326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1