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

Model Number	7214
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, balloon detachment and shaft break occurred.The target lesion was located in the severely calcified left anterior descending artery.A 3.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during inflation at 24 atmospheres, the balloon ruptured.As the physician pulled the balloon back, the balloon material hung up on the stent and came off the shaft.The tip of the catheter with the distal marker were still attached to the balloon.A non-bsc balloon was advanced and pushed the balloon fragment in the tip of the catheter.The physician went back down with another synergy stent and deployed it to trap the balloon material and the tip of the catheter up against the other stent and the vessel wall.Post dilatation was performed again with a non-bsc balloon catheter and completed the procedure.No patient complications were reported and the patient did well and was okay.

• 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: 9837108
• Report Number: 2134265-2020-02831
• Device Sequence Number: 13756265
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2022
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0024987041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention