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 01/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the ous affililate, a chpv with siphonguard was implanted and found not working approximately 3 weeks later.The device was replaced to fix the problem.

Manufacturer Narrative

The valve and catheters were returned for evaluation.The position of the cam when valve was received was 40mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was tested for programming and passed.The valve was flushed; no occlusion noted.The valve was leak tested and leaked only from the needle holes in the needle chamber.The catheters were irrigated, no occlusions noted.The valve was reflux tested and passed.The siphon guard was tested; no issues found.The valve was then pressure tested and passed.A review of manufacturing records found no discrepancies when the devices were released to stock.Based on the investigation, the reported issue could not be confirmed.The devices functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

Updated udi : (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the devices could not be performed.Review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.Refer to mdr 1226348-2018-10162 for information regarding the second device reported in this event.

• 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
• MDR Report Key: 7278202
• MDR Text Key: 100321399
• Report Number: 1226348-2018-10163
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K003322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 82-3072
• Device Lot Number: 147720
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention