MAUDE Adverse Event Report: Merit Maquiladora Mexico, S. DE R.L. DE C.V. Performa®; Catheter, Intravascular, Diagnostic

Catalog Number	7757-2MP65/B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Malfunction

• Brand Name: Performa®
• Common Device Name: Catheter, Intravascular, Diagnostic
• Manufacturer (Section D): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer (Section G): Merit Maquiladora Mexico, S. DE R.L. DE C.V.; avenida sor juana ines; 19970 interior b, edificio 2; tijuana, baja california 22630 ; MX 22630
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50459046
• Report Number: 3011642792-2026-00203
• Device Sequence Number: 9973030
• Product Code: DQO
• UDI-Device Identifier: 00884450766507
• UDI-Public: 00884450766507
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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
• Device Catalogue Number: 7757-2MP65/B
• Device Lot Number: I3368032
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown