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 03/25/2017

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

It was not possible to investigate the complaint as no sample was returned for evaluation.If the sample is returned in the future, this complaint will be re-opened and evaluated.A search for relative complaint for the same issue was not possible as the lot numbers were unknown for both devices.Review of the history device records for the valve was not possible as the lot number was unknown.Review of the history device records for the bactiseal catheter was not possible as the lot number was unknown.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.Device not available.

Manufacturer Narrative

It was previously reported that the device would not be returned.Subsequently the device was provided for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the images were taken of the valve ¿as received¿.The valve was visually inspected; no defects noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.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 valve was leak tested, no leaks noted.The catheters were irrigated, no occlusions were noted.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The valve passed the test.The valve was dried.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3115, with lot cplcb1, conformed to the specifications when released to stock on the 21st october 2013.Review of the history device records for the catheter was note possible at the lot number was unknown.No root cause could be determined, as the problem reported by the customer could not be duplicated.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: 6538221
• MDR Text Key: 74215607
• Report Number: 1226348-2017-10299
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• 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: 06/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2017
• 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