MAUDE Adverse Event Report: RAYNHAM PROG VALVE INLINE; CHPV

Catalog Number 823164

Device Problem Separation Problem (4043)

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

Event Date 04/21/2019

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the proximal catheter came off during implant.Therefore it was replaced with another valve.Also the surgeon suspected that there was a foreign material inside the valve.

Manufacturer Narrative

Udi information (b)(4).Sample was received for evaluation.Images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 110mmh2o.The valve was visually inspected: needle holes in the needle chamber and biological debris were noted.No catheters were returned.The valve was hydrated.The valve was tested for programming and the valve passed the test.The valve was flushed and the valve passed the test no occlusion was noted.The valve was leak and the only leaked from the needle holes over the needle guard.The valve was reflux tested per tm-100313 rev.10 the valve failed the test.The valve was dried.The valve was then pressure tested and 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, and on the seat of ruby ball.The root cause for the pressure issue is due to the biological debris found on the spring, on the spring pillar, on the ruby ball, and on the seat of the ruby ball, the biological debris was not letting the ruby ball sit correctly.Manufacturing records were reviewed and found no anomalies.Based on the results of the investigation, the reported issue is confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: PROG VALVE INLINE
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8568709
• MDR Text Key: 143701614
• Report Number: 1226348-2019-00123
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• 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: 04/25/2019

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: 09/30/2008
• Device Catalogue Number: 823164
• Device Lot Number: 1119301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1