MAUDE Adverse Event Report: Merit Maquiladora Mexico BIG60¿; Angiographic injector and syringe

Catalog Number	ENDO-AN6012
Medical Device Problem Codes	No Device Output (1435); No Pressure (2994)
Health Effect - Clinical Codes	Pneumothorax (2012); Perforation of Esophagus (2399)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that the pressure monitoring gauge did not register any pressure reading during balloon inflation.Subsequently, the patient sustained an esophageal perforation, described as a moderate focal full-thickness tear measuring approximately 2 cm in diameter at approximately 22 cm from the incisors.Following the perforation, the patient developed a pneumothorax and required chest tube placement for management.
Additional Manufacturer Narrative
The suspected device was not returned for evaluation.No images or videos were provided by the customer for evaluation.The complaint could not be confirmed.The root cause could not be determined.Search of the complaint database and product history record could not be performed as no lot number was provided.Investigation will be skipped.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: BIG60¿
• Common Device Name: Angiographic injector and syringe
• Manufacturer (Section D): Merit Maquiladora Mexico; avenida sor juana ines de; 19970 interior b, edificio 2; tijuana baja california 22630 ; MX 22630
• Manufacturer (Section G): Merit Maquiladora Mexico; avenida sor juana ines de; 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 ; +1(801)208-4225
• MDR Report Key: 50256388
• Report Number: 3011642792-2026-00170
• Device Sequence Number: 10125505
• Product Code: PTM
• UDI-Device Identifier: 00884450860373
• UDI-Public: 00884450860373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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?: No
• Device Catalogue Number: ENDO-AN6012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown