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

Model Number	00884450003145
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
Initially, the account alleges that during the procedure the catheter was leaking and that no harm came to the patient.One month later, the account states that the patient involved in the procedure has died.No additional information about this event has been provided.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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.Additional clinical information was received (via e-mail) from world health and from the physician, about the patient (child) death.The physician alleges that the actual cause of death was confirmed to be "heart failure, secondary to severe pulmonary hypertension".Pre-existing medical conditions confirmed to be severe pulmonary hypertension.The patient's prognosis was considered poor.The physician states that there was no association between the patient death and the use of the merit catheter.Date the patient expired was (b)(6) 2021, 14 days post catheter procedure.The 4f catheter was used for a coronary angiogram and av blood sampling procedure.The catheter leak was identified by the physician during the primary angiography procedure and was exchanged.The catheter was not a reprocessed catheter.

• Brand Name: PERFORMA
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 11778312
• Report Number: 3011642792-2021-00005
• Device Sequence Number: 3535713
• Product Code: DQO
• UDI-Device Identifier: 00884450003145
• UDI-Public: 00884450003145
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2023
• Device Model Number: 00884450003145
• Device Catalogue Number: 7708-30/B
• Device Lot Number: I1876764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death