MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. INQWIRE GUIDEWIRE

Catalog Number	IQ35F150J3S/B
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a pulmonary vein isolation procedure with the patient under sedation with propofol, a tamponade occurred requiring thoracic surgery.After successful transseptal puncture, the left superior and inferior pulmonary vein were isolated.After deflating and retracting the balloon catheter from the left inferior pulmonary vein, there was a drop in blood pressure.A transthoracic echography revealed accumulating pericardial blood.With a pericardial puncture >750ml of blood was withdrawn and it was decided to do emergency thoracic surgery.This revealed a 2 cm antero-superior tear of the left inferior pulmonary vein.The tear was sutured and the patient stabilized.The patient was moved to the icu for further observation.It is alleged that while switching to the left inferior pulmonary vein, the guide wire protruded out of the balloon catheter causing a tear.This was not noticed at first and the guide wire was advanced in the direction of the left inferior pulmonary vein.The balloon was then advanced and inflated.After deflating, the balloon no longer blocked the tear and the tamponade was then noted.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record and complaint database could not be performed as a lot number was not provided.If the device is returned at a later date, the complaint will be reopened and a complete investigation will be performed.

• Brand Name: INQWIRE GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 22061204
• Report Number: 9616662-2025-00017
• Device Sequence Number: 8478689
• Product Code: DQX
• UDI-Device Identifier: 00884450023563
• UDI-Public: 00884450023563
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Catalogue Number: IQ35F150J3S/B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/01/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown