MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERFORMA BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	7521-13/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during an urgent coronary angiography [stemi] procedure on a 32 yo patient, it was revealed there was a partial dissection of the left main trifurcation involving the ria, rim , and rcx arteries.This resulted in total obstruction of the ramus intermediate mammary [rim] and the right coronary [rc] arteries.The patient suffered from cardiogenic shock and increased heart rate during this procedure.It cannot be determined whether the coronary dissection was purely iatrogenic or spontaneous in nature.Immediate pci and reconstruction of these arteries successfully took place utilizing five drug-eluding stents [des] resulting in the restoration of coronary perfusion, hemodynamic stabilization, and an acceptable heart rate.No additional patient consequences have been reported.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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 search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERFORMA BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16911282
• Report Number: 3011642792-2023-00034
• Device Sequence Number: 20392179
• Product Code: DQO
• UDI-Device Identifier: 00884450002919
• UDI-Public: 884450002919
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K943739
• 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): 05/10/2023

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: 7521-13/A
• Device Lot Number: I2605070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown