MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND MERIT CUSTOM KITS

Catalog Number K12T-06536

Device Problems Fracture (1260); Material Fragmentation (1261)

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

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an intravascular procedure, a guidewire tip detached within the patient's artery.The clinician was successful in removing the foreign body with a vascular snare device.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually and microscopically.The complaint is confirmed.The root cause could not be determined however, it is possible that the reported incident was caused by over manipulation of the guidewire during the procedure.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: MERIT CUSTOM KITS
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester, va
• MDR Report Key: 9881122
• MDR Text Key: 186546879
• Report Number: 1125782-2020-00001
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 00884450349038
• UDI-Public: 884450349038
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: K12T-06536
• Device Lot Number: T1728233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention