MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLINE VLV W/ SPHNGRD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8805

Device Problem Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2018

Event Type  malfunction  

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 certas with siphonguard was blocked during surgery.The procedure was insertion of a v-p shunt.It was reported that csf did not work from the distal catheter, prior to implant.The surgeon used negative pressure with a needle and a syringe, but csf did not flow.The valve was removed from the patient.The sales rep confirmed that the saline was not flow from the distal of the valve.They tried to prime the proximal portion of the valve, then leakage of saline from the valve body was confirmed.The surgeon commented that the valve was a defective product, so it was not used.No further information was provided by hospital.

Manufacturer Narrative

Udi : (b)(4).The device was returned for evaluation.The position of the cam when valve was received was at setting 6.The valve was visually inspected; no defects noted.The valve was tested for programming and passed.The valve was flushed; no occlusions were noted.The valve was leak and reflux tested; no issues found.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested and passed.A review of manufacturing records found that the device conformed to specification when released to stock.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CERTAS INLINE VLV W/ SPHNGRD
• 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: 7732565
• MDR Text Key: 115472517
• Report Number: 1226348-2018-10523
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704071372
• UDI-Public: (01)10886704071372(10)177833
• Combination Product (y/n): N
• PMA/PMN Number: K112156
• 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: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 82-8805
• Device Lot Number: 177833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1