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

Catalog Number	IQ35F210J1O5/B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
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 radial approach diagnostic heart cath the cardiologist experienced trouble removing the diagnostic catheter.The inqwire guide wire couldn't be removed from the sheath.While pulling the sheath and wire out together, the tip of the wire detached in the right distal radial artery.The patient went to secondary surgery involving right radial embolectomy, removal of intra-arterial foreign body, and primary repair of the artery.No additional patient consequence to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.If product returns at a later date this report will be reopened and a full investigation will be performed.

• 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, ; EI
• MDR Report Key: 12046720
• Report Number: 9616662-2021-00011
• Device Sequence Number: 11765713
• Product Code: DQX
• UDI-Device Identifier: 00884450196373
• UDI-Public: 884450196373
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 02/02/2024
• Device Catalogue Number: IQ35F210J1O5/B
• Device Lot Number: K2041175
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/15/2021
• 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: Hospitalization; Life Threatening; Required Intervention