MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7213
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was extremely tight in a st-segment elevation myocardial infarction case.A 3.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during procedure, the balloon ruptured.Another 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation but it also ruptured during procedure.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was extremely tight in a st-segment elevation myocardial infarction case.A 3.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during procedure, the balloon ruptured.Another 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation but it also ruptured during procedure.There were no patient complications nor injuries reported.It was further reported that the target lesion was extremely tight and the balloons were inflated at 8 atmospheres.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was extremely tight in a st-segment elevation myocardial infarction case.A 3.00mm x 15mm emerge balloon catheter was advanced for dilation.However, during procedure, the balloon ruptured.Another 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation but it also ruptured during procedure.There were no patient complications nor injuries reported.It was further reported that the target lesion was extremely tight.The balloons were inflated at about 8 atmospheres.It was further reported that the patient had a critical ostial left anterior descending artery stenosis.
Additional Manufacturer Narrative
(a3) sex - updated (b5) describe event or problem - updated (b7) other relevant history - updated.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11339978
• Report Number: 2134265-2021-01902
• Device Sequence Number: 3472785
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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: 01/08/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0026600788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/22/2021; 03/15/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/02/2021; 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1