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

Model Number	7213
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10260876
• Report Number: 2134265-2020-08696
• Device Sequence Number: 19697533
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/10/2020

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: 03/25/2022
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0025403980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/10/2020
• 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: Other; Required Intervention
• Patient Age: 75 YR