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

Model Number 7213

Device Problem Deflation Problem (1149)

Patient Problem Bradycardia (1751)

Event Date 06/21/2020

Event Type  Injury  

Event Description

It was reported that balloon deflation issue occurred and patient experienced bradycardia.The target lesion was located in the left anterior descending artery (lad).A 2.50mm x 15mm nc emerge balloon catheter was advanced and initially inflated at 8 atmospheres for 15 seconds with a non-bsc inflation device.However, during the second inflation at 6 atmospheres for 10 seconds, the balloon failed to deflate.A second non-bsc inflation device was used to deflate the balloon.The prolonged inflation cut off blood to the distal portion of the lad and the patient experienced symptomatic bradycardia.Subsequently, the patient was treated with emergency medications and cardiopulmonary resuscitation.After the patient was stabilized, the procedure was completed with stent placement in the lad.No further patient complications were reported and the patient recovered.

• 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: 10260876
• MDR Text Key: 198493212
• Report Number: 2134265-2020-08696
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0025403980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• 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): Other; Required Intervention
• Patient Age: 75 YR