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

Model Number	7145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapmnet occurred.A 2.25mm x 30mm emerge balloon catheter was selected for use.However, it was noted that the wire became stuck in the balloon.The procedure was completed with another stent.There were no complications reported and the patient is stable.

• Brand Name: 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: 11558165
• Report Number: 2134265-2021-03138
• Device Sequence Number: 17194543
• Product Code: LOX
• UDI-Device Identifier: 08714729807018
• UDI-Public: 08714729807018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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
• Report Date (Section B): 03/23/2021

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: 08/15/2022
• Device Model Number: 7145
• Device Catalogue Number: 7145
• Device Lot Number: 0025837935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1