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

Model Number 7214

Device Problems Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2020

Event Type  Injury  

Event 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9837108
• MDR Text Key: 183727065
• Report Number: 2134265-2020-02831
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention