MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT LAUREATE.GUIDE WIRE; HYDROPHILIC COATED GUIDEWIRE

Catalog Number	LWSTFA35180/D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
During a peripheral angiogram, the guidewires hydrophilic coating detached within the patient's right leg.The physician was not able to retrieve the foreign body from the patient.The procedure was cancelled.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.A search of the complaint database found no similar complaints for this lot number from the same customer.The device history record was reviewed, and no exception documents were found.

• Brand Name: MERIT LAUREATE.GUIDE WIRE
• Common Device Name: HYDROPHILIC COATED GUIDEWIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11233316
• Report Number: 9616662-2021-00002
• Device Sequence Number: 19640690
• Product Code: DQX
• UDI-Device Identifier: 00884450033340
• UDI-Public: 884450033340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 08/09/2023
• Device Catalogue Number: LWSTFA35180/D
• Device Lot Number: LWSTFA35180/D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDECATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention