MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD MERIT LAUREATE GUIDE WIRE

Model Number	00884450033289
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
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 a peripheral vascular procedure, the hydrophilic guidewire tip detached within the patient.The physician had acquired retrograde femoral artery access and had negotiated the patient's common iliac bifurcation.During guidewire manipulations within the patient's calcified common iliac artery the guidewire tip detached.The physician used a vascular snare device to successfully retrieve the foreign body from the patient.The patient tolerated the procedure well and was discharged to home with no additional consequences to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined as there is a possibility it is use related.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 LAUREATE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• MDR Report Key: 10584502
• Report Number: 9616662-2020-00012
• Device Sequence Number: 3028038
• Product Code: DQX
• UDI-Device Identifier: 00884450033289
• UDI-Public: 00884450033289
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/17/2020

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: 02/28/2023
• Device Model Number: 00884450033289
• Device Catalogue Number: LWSTDA35150/D
• Device Lot Number: K1863271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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