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

Catalog Number	5583-23/B
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The account reports during an atrial fibrillation ablation, a vascular dissection occurred which resulted in a pericardial effusion.The ablation catheter and sheath were placed at the coronary sinus.When injecting the contrast agent into the coronary sinus using the 5f vertebral diagnostic catheter, an obstruction was noted.When removing the sheath from the coronary sinus, a dissection in the coronary sinus was observed.The patient was observed and remained hemodynamically stable.No intervention was required.Ultrasound was completed which diagnosed the effusion.The effusion resolved on its own without medical or surgical treatment and the patient is stable.
Additional Manufacturer Narrative
The suspect medical device was not returned 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.Should the device be returned later, the investigation will be reopened.

• Brand Name: PERFORMA®.BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 20258467
• Report Number: 3011642792-2024-00060
• Device Sequence Number: 18028758
• Product Code: DQO
• UDI-Device Identifier: 00884450002506
• UDI-Public: 884450002506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/09/2024

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: 5583-23/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/19/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown