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

Catalog Number	1624-B420M/JP
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The unit was examined visually.The complaint is confirmed.The root cause is attributed to the manufacturing process.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 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
The account alleges that during a thoracic endovascular aortic repair [tevar] procedure, the radiopaque marker on the catheter detached and migrated between the endovascular stent graft and aortic vessel wall.The physician had acquired arterial vascular access and had delivered a guide catheter over a guide wire through the descending aorta to the thoracic aneurysm and successfully deployed two aortic stent grafts.During catheter manipulations, the marker band detached and migrated off the guide wire and drifted between stent graft and aortic vessel wall.The physicians attempt to retrieve the radiopaque marker from the patient were unsuccessful.The physician then ballooned the graft in position, pinning the marker between the graft and the aortic vessel wall.The procedure was completed successfully with no additional consequences to the patient.

• Brand Name: PERFORMA DIAGNOSTIC CATHETER
• Common Device Name: DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9151971
• Report Number: 3010665433-2019-00064
• Device Sequence Number: 2782052
• Product Code: DQO
• UDI-Device Identifier: 00884450283134
• UDI-Public: 00884450283134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 1624-B420M/JP
• Device Lot Number: E1566148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1