MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD INQWIRE® DIAGNOSTIC GUIDE WIRE

Model Number	00884450011133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A search of the complaint database was performed and one similar complaint from the same facility for this lot number was found.The device history record was reviewed, and no exception documents were found.
Event or Problem Description
The account alleged that during an endovascular procedure, the guidewire fractured within the patient's vasculature.No patient injury was reported.

• Brand Name: INQWIRE® DIAGNOSTIC GUIDE WIRE
• Common Device Name: DIAGNOSTIC GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, H91 W 274; EI H91 W274
• MDR Report Key: 9805500
• Report Number: 9616662-2020-00005
• Device Sequence Number: 13613812
• Product Code: DQX
• UDI-Device Identifier: 00884450011133
• UDI-Public: 00884450011133
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/08/2020

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: 09/30/2021
• Device Model Number: 00884450011133
• Device Catalogue Number: IQ35F260J3/B
• Device Lot Number: K1442685
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2020
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR