MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND INQWIRE® AMPLATZ.; STIFF GUIDE WIRE

Catalog Number	IQA502
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a pfo closure procedure, the guidewire became stuck in the patient's atrium.The physician acquired right antegrade femoral access and successfully advanced an mpa1 guide catheter into the patient's left atrium.During guidewire manipulations, the wire became stuck within the patient's pulmonary artery.The patient was transferred to the surgical unit for possible interventions.The cardiac interventional team was on standby as the clinician vigorously removed the frayed guidewire.No patient injuries or interventional consequences to report.
Additional Manufacturer Narrative
The alleged medical device was returned for a full investigation.The complaint is confirmed, but the root cause could not be determined.The device history record was reviewed, and no exception documents have been identified.A search of the complaint database was performed and no similar complaints for this lot number have been identified.

• Brand Name: INQWIRE® AMPLATZ.
• Common Device Name: STIFF GUIDE WIRE
• 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 bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18314756
• Report Number: 9616662-2023-00021
• Device Sequence Number: 6784000
• Product Code: DQX
• UDI-Device Identifier: 00884450239476
• UDI-Public: 884450239476
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K2747214
• 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,Followup
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2026
• Device Catalogue Number: IQA502
• Device Lot Number: K2747214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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: ICE CATHETER; INTERVENTIONAL GUIDECATHETER
• Patient Sex: Unknown