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

Catalog Number 7503-21/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Vascular Dissection (3160)

Event Date 09/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a diagnostic procedure, the catheter was successfully introduced into the patient.While inside the artery, the clinician attempted to rotate the catheter.There was resistance to rotation before it unexpectedly gave way and rotated causing the device to go deep within the artery and dissect the arterial wall.Additional medical/surgical intervention was necessary and a stent graft was placed to cover the dissection.No additional patient consequence to report.

Manufacturer Narrative

The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: PERFORMA® CATHETER
• Type of Device: 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 ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17958910
• MDR Text Key: 325966754
• Report Number: 3011642792-2023-00067
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450003121
• UDI-Public: 884450003121
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7503-21/A
• Device Lot Number: I2506990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening