MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS INLIN VLV SPHN/UNIT CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8806

Device Problems Partial Blockage (1065); Improper Flow or Infusion (2954); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The valve was implanted to the patient via lp-shunt with setting 4.Doi was unknown.The tool kit was used perpendicular to the valve.It was reported that the pressures setting was not able to be changed when the surgeon tried to change the setting under fluoroscopic control.When the contrast was flowed, it did not seem to flow to the abdominal catheter.There was no possibility that the indicator was dropped.The surgeon palpated the valve placing site before placing the locator, and marked the position of the center, proximal and distal connectors of the valve.The low profile locator was used.The skin tissue did not protrude in the valve cutout part of the locator.The thickness of the skin tissue on the valve was within 10 mm.The valve blockage was confirmed by clinical symptoms, size of the ventricle and pumping.The blockage was confirmed with the proximal catheter, the distal catheter and valve.The current setting was confirmed by x-ray.The revision surgery is going to performed on (b)(6) 2017.The product will be returned to your site.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The valve was returned for evaluation.The position of the cam when valve was received was at setting 3.The valve was visually inspected; no defects were noted.A siphon guard was also returned, but not attached to the valve.The valve was hydrated and tested for programming.The valve passed the test.The valve was flushed.No occlusion was noted.The valve was leak tested and only leaked from the needle holes on the needle chamber.The valve was reflux tested and passed the test.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested and passed.Review of the history device records was not possible as the lot number was unknown.Based on the results of the evaluation, 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 INLIN VLV SPHN/UNIT CAT
• 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: 7169254
• MDR Text Key: 96539588
• Report Number: 1226348-2018-10027
• Device Sequence Number: 1
• Product Code: JXG
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-8806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Date Manufacturer Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention