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

Model Number	7135
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon edge extended past the markerband.The 80% stenosed target lesion was located in the non- tortuous and mildly calcified left anterior descending artery.A 2.50mm x 30mm emerge balloon catheter was advanced for pre-dilatation.However, when the balloon was inflated at 18 atmospheres, it was observed that the balloon edge extended well past the markerband.The procedure was completed with no patient complications reported, and the patient was fine.

• 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: 9819531
• Report Number: 2134265-2020-02596
• Device Sequence Number: 19274295
• Product Code: LOX
• UDI-Device Identifier: 08714729806417
• UDI-Public: 08714729806417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113220
• 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
• Report Date (Section B): 03/11/2020

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: 07/08/2022
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0024745352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1