MAUDE Adverse Event Report: RAYNHAM PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823162

Device Problem Infusion or Flow Problem (2964)

Patient Problems Injury (2348); Lethargy (2560)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A surgeon reported the hakim valve was not flushing and was revised/explanted.The valve was implanted on (b)(6) 2020 and on (b)(6) 2020 the patient presented with lethargy and emesis; there was no runoff thru the valve and the surgeon could not flush anything thru the valve; therefore, it was explanted and replaced with a new hakim.

Manufacturer Narrative

Updated fields - d1, d2, d4, d10, g4, g7, h2, h3, h4, h6, h10.Unique device identifier (udi) : (b)(4).The hakim valve was returned for evaluation: review of the history device records for the valve, product code 82-3162 with lot 3621625, conformed to the specifications when released to stock on the 23rd april 2019.Failure analysis - 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 passed the for programming, occlusion, leaks, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the valve mechanism, but at the time of investigation no issues were noted.

Event Description

N/a.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10465625
• MDR Text Key: 204729147
• Report Number: 3013886523-2020-00059
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: 07/18/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR