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

Catalog Number 823162

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 06/26/2021

Event Type  Injury  

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 Description

A physician reported that the codman hakim programmable valve with sg was implanted to a (b)(6)-year-old male patient with cerebral hemorrhage and protein c deficiency, via v-p shunt on (b)(6) 2018 with a setting of 150mmh2o.However, obstruction was observed, and it was found that the contrast agent did not flow.Therefore, it was replaced to a new one (hakim) on (b)(6) 2021.The patient has since recovered.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 192573 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 150mmh2o.The valve was hydrated.The valve was leak tested and only leaked from the needle hole.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.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 issue 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 Description

N/a.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12216546
• MDR Text Key: 263088499
• Report Number: 3013886523-2021-00324
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 823162
• Device Lot Number: 192573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 YR