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

Model Number	82-3008
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the sales rep, after two weeks after insertion in to a canine patient, in an off-label application, the hakim precision valve became obstructed and was revised.The dog is doing well post-revision.
Additional Manufacturer Narrative
Udi : (b)(4).The valve was returned for evaluation.The valve was visually inspected: some biological debris was noted inside the valve as well as needle holes over the needle guard.The valve was flushed; no occlusion was noted.The valve was leak tested and only leaked from the needle holes over the needle guard.The valve was reflux tested and failed.The valve was then pressure tested and failed.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 and on the seat of the ruby ball.A review of manufacturing records found that the device conformed to specification when released to stock.The root cause for the pressure problem is due to biological debris found on the ruby ball and the seat of the ruby ball, the biological debris was stopping the ruby ball from being seated correctly.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN HAKIM PRECISION FIXED PRESSURE VALVE
• Common Device Name: 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: 7736250
• Report Number: 1226348-2018-10530
• Device Sequence Number: 2771663
• Product Code: JXG
• UDI-Device Identifier: 10886704041023
• UDI-Public: (01)10886704041023
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 82-3008
• Device Catalogue Number: 82-3008
• Device Lot Number: CPMB5F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention