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

Model Number	7214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via user medwatch mw5104199 that balloon rupture occurred.A 2.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The device was withdrawn through the catheter intact.There were no patient complications reported.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: 12626664
• Report Number: 2134265-2021-12839
• Device Sequence Number: 1428004
• Product Code: LOX
• UDI-Device Identifier: 08714729846611
• UDI-Public: 08714729846611
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 03/27/2023
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0027046005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1