MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3072

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 01/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

Shunt implanted and found not working.

Manufacturer Narrative

Device evaluation: concomitant medical products, date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative.Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 60 mm h2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was hydrated for 24 hours.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The catheters were irrigated, no occlusions were noted.The valve was leak tested, the valve leaked from the needle holes in the needle chamber.The valve was reflux tested, the valve failed the test.The valve was dried.The valve was then pressure tested, the valve failed the test.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 cam mechanism pillar, and on the base plate.The cam magnets were also controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3832, with lot cvgb7n, conformed to the specifications when released to stock on the 5th july 2016.There were - 49 parts released to stock.Review of the history device records for the bactiseal catheters was not possible as the lot number was unknown.The root cause for the pressure problem found during investigation 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 cam mechanism pillar, and on the base plate.No problem found with the bactiseal catheters.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL
• 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6301421
• MDR Text Key: 66525686
• Report Number: 1226348-2017-10085
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention