MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV UNITIZED

Catalog Number 823114

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 07/14/2021

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 a suspected obstruction of a hakim valve.The valve was implanted to the patient via v-p shunt on (b)(6) 2021 with an unknown setting.The valve was removed and replaced on (b)(6) 2021.It is unknown how the obstruction was discovered and is unknown if the patient experienced any signs and symptoms.The patient is in follow up status.

Manufacturer Narrative

The valve was returned for evaluation.Failure analysis - the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 140mmh2o.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux 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 occlusion issues were noted.

Event Description

N/a.

• Brand Name: MICRO CHPV UNITIZED
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12289055
• MDR Text Key: 265428475
• Report Number: 3013886523-2021-00346
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 823114
• Device Lot Number: 3303259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1