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

Model Number 00884450003145

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2021

Event Type  Death  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 11778312
• MDR Text Key: 249083540
• Report Number: 3011642792-2021-00005
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450003145
• UDI-Public: 00884450003145
• Combination Product (y/n): N
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death