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

Catalog Number 82-3842

Device Problem Complete Blockage (1094)

Patient Problem Hydrocephalus (3272)

Event Date 05/16/2018

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 ventricular catheter of the hakim programmable valve was blocked after implantation.The patient developed hydrocephalus and the device was removed.The valve was implanted to the patient via vp-shunt due to normal pressure hydrocephalus after sah.The initial setting is unknown.A ct scan was done that revealed ventricular enlargement.A contrast study was done, the ventricular catheter was not completely blocked but the flow could be confirmed to the abdominal cavity.Removal surgery was performed, without replacement.The patient had a cyst in the abdomen and the protein value was also a little higher; although, the specific value was unknown.

Manufacturer Narrative

The device was returned for evaluation.The position of the cam when valve was received was 70mmh2o.The valve was visually inspected; no defects 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 noted.The catheters were 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 no discrepancies when the device was released to stock.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.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. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7583433
• MDR Text Key: 110522880
• Report Number: 1226348-2018-10397
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 82-3842
• Device Lot Number: CRJBNW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR