MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INQWIRE®.GUIDE WIRE; CATHETER GUIDEWIRE

Catalog Number	IQ35F150BST/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device will not be returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that upon survey data review for the inqwire product family, an adverse event involving a diagnostic inqwire was noted.The event alleges that the guide wire may have caused a embolism during stent placement within a patient's peripheral vascular system.Additional medical intervention was required.No additional details are available, and the device will not be returning for investigation.

• Brand Name: INQWIRE®.GUIDE WIRE
• Common Device Name: CATHETER GUIDEWIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14939966
• Report Number: 9616662-2022-00009
• Device Sequence Number: 19956703
• Product Code: DQX
• UDI-Device Identifier: 00884450029909
• UDI-Public: 884450029909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: IQ35F150BST/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER; VASCULAR STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female