MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND MERIT CUSTOM KITS

Catalog Number	K12T-06536
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester, va
• MDR Report Key: 9881122
• Report Number: 1125782-2020-00001
• Device Sequence Number: 742221
• Product Code: DQR
• UDI-Device Identifier: 00884450349038
• UDI-Public: 884450349038
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention