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

Catalog Number NS9008

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

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 lumbar catheter migrated after implantation and the was revised.The valve was implanted to the patient; however, initial setting was unknown.The patient gained 7 kg in this a half year.Probably, under fat influence, a lumber catheter came out from the patient.The revision surgery was performed and there was no adverse consequence to the patient no further information was provided by hospital reported.

Manufacturer Narrative

The device was returned for evaluation.The valve was visually inspected; some biological debris was noted inside the valve mechanism as well as cuts/tears in the silicone housing.The position of the cam when valve was received was 150mmh2o.The valve was tested for programming: the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed; the valve failed, an occlusion was noted.The catheter was irrigated, no occlusion was noted.The siphon guard was detached from the valve and was tested; no issues found.The cam mechanism was moved.The valve was retested for programming and failed the test, the cam mechanism did not move during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring on the spring pillar on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the base plate.The cam magnets were tested, passed.A review of manufacturing records found that the product conformed to specification when released to stock.The root cause for the programming problem and occlusion is due to the biological debris found on the spring on the spring pillar on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the base plate.The root cause for the cuts/tears in the silicone housing is due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu silicone has a low tear/cut resistance.The root cause for the migrating catheter could not be determined.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7718030
• MDR Text Key: 114956989
• Report Number: 1226348-2018-10506
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704073161
• UDI-Public: (01)10886704073161(11)141002(17)190831(10)CRLBF2
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: NS9008
• Device Lot Number: CRLBF2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 09/26/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR