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

Catalog Number 823832

Device Problem Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2021

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

1 of 3 reports.Other mfg report numbers: 3013886523-2021-00287.3013886523-2021-00288.A facility reported a codman hakim programmable valve and catheters (823073 and 823074) were implanted into a (b)(6) patient on (b)(6) 2021 with removal of the device occurring 30 minutes later.The physician found that there was no cerebral spinal fluid flowing out from the abdominal catheter.The physician disconnected the abdominal catheter with the valve and there was no cerebral spinal fluid flowing out from the valve.Due to the patients age, the physician retrieved the hakim valve and catheters and changed with the device of another company to complete the procedure and limit the anesthesia time.A 30-minute surgical delay was reported due to the shunt adverse event.The patient is stable.

Manufacturer Narrative

The valve was returned for evaluation.Device history record (dhr): the product code 823832 with lot 4302823 conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; no defects were noted.The position of the cam when valve was received was 100mmh2o.The valve was hydrated.The catheters were irrigated no occlusions were noted.The valve was leak tested and no leaks noted.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: 12116215
• MDR Text Key: 260240953
• Report Number: 3013886523-2021-00286
• 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
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 4302823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1