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

Catalog Number 823832

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Swelling/ Edema (4577)

Event Date 05/18/2021

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 facility reported a codman hakim programmable valve was implanted in a patient on (b)(6) 2021.The patient recovered well after the procedure and head ct was performed.Four months after the procedure, there was swelling noted under patient's retro auricular and jugular skin.On (b)(6) 2021, the patient went to the hospital for a follow-up visit and was found abnormal when pressing the needle chamber of the hakim valve.The patient had a head ct scan performed and it was identified the valve was dislodged at the ventricular.On (b)(6) 2021, the patient was taken to the operating room and the physician conducted the revision procedure and implanted the patient with another of the same valve.The physician found that the needle chamber was dislodged with the valve.

Event Description

N/a.

Manufacturer Narrative

Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10.The valve was returned for evaluation.Device history record (dhr) - review of the history device records was not possible as the lot numbers given by the customer did not correspond to the received valve.Failure analysis - the valve was visually inspected; it was noted that the needle base in the needle chamber was missing (not returned).The needle chamber was visually inspected; marks were noted in the silicone housing.No catheters were retuned with the valve.The position of the cam when valve was received was 100mmh2o.The valve was hydrated.The valve could not be flushed and pressure tested due to the missing needle guard.The valve passed the test for programming, reflux and siphon guard.The root cause for the marks in the silicone housing in the needle chamber is probably due to wrong handling, as noted in the "ifu": silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.The root cause for the missing needle guard as reported by the customer is probably due to wrong handling, using unshod clamp/forceps as noted in the "ifu": silicone has a low cut/tear resistance.Do not use sharp instruments when handling the silicone valve or catheter, use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.The root cause for the problem reported by the customer ¿found that the valve was dislodged at the ventricular end.Based on a photo provided by the customizer, is possibly due to not tying the catheter to the valve connector as no ties were noted in the photo.

• 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: 11956729
• MDR Text Key: 254815023
• Report Number: 3013886523-2021-00250
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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: 4469567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1