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

Catalog Number	IQ35F180J1O5RS
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return 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 customer reports a large effusion was noticed after the ablation procedure was completed.The physician states that they did attempt to advance the guidewire against inner tissues multiple times.The patient tolerated the procedure well.No additional patient consequences to report.

• Brand Name: INQWIRE® J ROSEN
• Common Device Name: WIRE, GUIDE
• 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 ; 8012088662
• MDR Report Key: 19760330
• Report Number: 9616662-2024-00022
• Device Sequence Number: 18428179
• Product Code: DQX
• UDI-Device Identifier: 00884450196380
• UDI-Public: 00884450196380
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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: IQ35F180J1O5RS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ABLATION CATHETER.; MAPPING CATHETER.; TRANSEPTAL NEEDLE.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown