MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT LAUREATE GUIDE WIRE

Catalog Number	LWSTFA35180/D
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2019
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
The account alleges that during bilateral recanalization of an iliac artery, 5cm of the hydrophilic guidewire tip detached within the patient's vasculature.The physician had acquired retrograde arterial vascular access and during guidewire and catheter manipulations within the common iliac artery, the tip detached with the patient.The physician noted that during guidewire manipulations, resistance and tortuosity was not experienced during wire manipulations.The physician deployed a covered peripheral vascular stent-graft to both treat the patient's vasculature disease and entrap the detached wire tip between the arterial lumen and stent-graft, preventing wire tip migration.The patient tolerated the procedure well.No additional consequences to report.
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 one similar complaint 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: GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; ballybrit, ; EI
• MDR Report Key: 9385096
• Report Number: 9616662-2019-00016
• Device Sequence Number: 16696213
• Product Code: DQX
• UDI-Device Identifier: 00884450033340
• UDI-Public: 00884450033340
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K141295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: LWSTFA35180/D
• Device Lot Number: K1554975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1