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

Model Number	7212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via user/facility medwatch# (b)(4) that balloon rupture occurred.The 70-80% stenosed target lesion was located in the left anterior descending artery.After engaging a 6 fr ebu 3.0 guide catheter and placing a non-bsc wire, pre-dilatation was performed with a 2.0 compliant balloon.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.The balloon was initially inflated at 22 atmospheres for 69 seconds; however, during the second inflation at 20 atmospheres for 22 seconds, the balloon ruptured.The device was completely removed and there were no patient complications reported.

• 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: 10509001
• Report Number: 2134265-2020-11561
• Device Sequence Number: 17021070
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: 08714729846376
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 03/05/2022
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0025309782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR