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

Model Number 7212

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

Event Description

It was reported that difficulty in removal was observed.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 3.50mm x 12mm nc emerge balloon catheter was having difficulty in advancing in predilating the vessel due to the winging of the balloon.Furthermore, the device was having difficulty in removal and the procedure was completed with a different device.No further complications reported.

• 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: 11987930
• MDR Text Key: 255944055
• Report Number: 2134265-2021-07595
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0027038922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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