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

Catalog Number 82-3842

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the hakim programmable valve had stator dislodgement approximately two years after implantation and was revised.Initial settings are unknown.The patient was examined for follow up, and it seemed that the cam was dislodged from the valve, so revision surgery was performed.The distance between the ruby ball and the cam part was from 3.91 mm to 5.36 mm.The surgeon commented that it was spreading due to cam dropping.No further information was provided by hospital.The products will be returned to your site.

Manufacturer Narrative

Udi -- (b)(4).The device was returned for evaluation.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was tested for programming and passed.The valve was flushed; no occlusion was noted.The valve was leak tested; no leaks were noted.The catheter was irrigated, no occlusions noted.The valve was reflux tested and passed.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested; no issues found.A review of manufacturing records found the device conformed to specification when released to stock.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROG VALVE INLINE SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7873861
• MDR Text Key: 120173201
• Report Number: 1226348-2018-10645
• 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
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 82-3842
• Device Lot Number: CTNB36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR