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

Catalog Number 7521-13/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 04/25/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

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
• Type of Device: 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
• MDR Text Key: 314999942
• Report Number: 3011642792-2023-00034
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450002919
• UDI-Public: 884450002919
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention