MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM INLINE PROGRAMMABLE VALVE SG; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 823162

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Failure of Implant (1924)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned and is awaiting evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the ous affiliate, after two years hakim programmable valve with siphonguard could not be reprogrammed and was revised.The patient was recovering well.The valve will be returned.

Manufacturer Narrative

The device was returned for evaluation.The position of the cam when the valve was received was at 60mmh20.The valve was visually inspected; a cut/tear in the silicone housing in the needle chamber was noted.The investigation of the returned device did not confirm the programming problem but did notice a cut/tear in the silicone housing in the needle chamber.The valve was tested for programming and passed.The valve could not be flushed due to the damaged silicone housing.The valve was leak tested, leaked from the cut/tear in the silicone housing.The valve was reflux tested and passed.The siphon guard was removed, tested and passed.It was not possible to pressure test due to the damaged silicone housing.A review of manufacturing records found no discrepancies when the device was released to stock.The most recent complaint and smt presentation was reviewed and did not show that this product family exceeded its upper control limit for complaints.Based on the results of the investigation, the reported issue was confirmed.The root cause for the damage silicone house is probably due to a sharp or pointed object coming into contact with the silicone.As noted in the ifu silicone has a low cut/tear resistance.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM INLINE PROGRAMMABLE VALVE SG
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8157104
• MDR Text Key: 130172175
• Report Number: 1226348-2018-10871
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2020
• Device Catalogue Number: 823162
• Device Lot Number: CVBCP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR