MAUDE Adverse Event Report: RAYNHAM MICRO CHPV W RICKHAM UNITIZED

Catalog Number 823113

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 07/29/2020

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 facility reported the ¿valve was unseated¿ and the patient was taken to the operating room for a shunt revision on (b)(6) 2020.The valve was removed, and a new valve was implanted.Unknown implantation date.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The valve was returned for evaluation.Device history record (dhr) - the lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 18th july 2006.Failure analysis - the valve was visually inspected; biological debris was noted, as well as the stator and x ray dot were dislodged and the rickham connector was broken off (broken connector not returned).The position of the cam could not be determined as the stator was dislodged.The valve was hydrated.Due to dislodged stator the could not be tested for programming, reflux and pressure.Due to broken connector, the valve could not be flushed and tested for leak.Under magnification: a crack and a bump mark were noted in the valve casing.Corrosion was noted on the stator and the x ray dot.The root causes for the dislodged stator and x ray dot could be partly due to the valve receiving a hard knock.The root cause for the bump mark and crack in the valve casing is due to the valve receiving a hard knock.The root cause for the broken rickham connector could be due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.The potential cause of failure for the problem reported by the customer is probably due to the valve receiving a hard knock.

• Brand Name: MICRO CHPV W RICKHAM UNITIZED
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10447393
• MDR Text Key: 204210464
• Report Number: 3013886523-2020-00058
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR