MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. 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	11/04/2019
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 a percutaneous transluminal peripheral vascular procedure, the hydrophilic guide wire tip detached within the patient.The physician had acquired retrograde arterial vascular access in an attempt to re-cannulate the patient's left common iliac artery.During guide wire manipulation's the tip detached.The physician used a vascular snare device to successfully retrieve the guide wire tip from the patient with no additional consequences to the patient.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to significant force being 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: LAUREATE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; ballybrit, ; EI
• MDR Report Key: 9371070
• Report Number: 9616662-2019-00015
• Device Sequence Number: 14178699
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: 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: 04/23/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/25/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention