MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND INQWIRE®; WIRE, GUIDE, CATHETER

Model Number	00884450046227
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device was not returned 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
Pmcf survey data alleges that a safety adverse event occurred while using a 0.035" j-tip diagnostic guidewire.During placement of a stent into the peripheral vasculature, vessel dissection occurred.Additional treatment was required; however, no additional details are available.

• Brand Name: INQWIRE®
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 14940028
• Report Number: 9616662-2022-00007
• Device Sequence Number: 19979242
• Product Code: DQX
• UDI-Device Identifier: 00884450046227
• UDI-Public: 00884450046227
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign
• 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 Model Number: 00884450046227
• Device Catalogue Number: IQ35F100J15/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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1-BALLOON CATHETER; 1-GUIDE CATHETER; 1-PERIPHERAL STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown