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

Model Number 7312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Ischemia (1942); Myocardial Infarction (1969); Pulmonary Edema (2020); Tachycardia (2095)

Event Date 11/11/2021

Event Type  Death  

Event Description

It was reported that patient death occurred. A live broadcast of a high risk percutaneous coronary intervention, with a culotte technique approach, was performed on a bifurcated lesion located in the left main, left circumflex, and ostial marginal artery. The patient was noted to have presented to the case in poor condition, with a history of diabetes. 035/180/3mm amplatz guidewire, 2. 00mm x 15mm emerge balloon, two 2. 50mm x 15mm emerge balloons, 4. 00mm x 12mm emerge balloon, 2. 25mm x 12mm emerge balloon, 4. 00mm x 6mm emerge balloon, 2. 25 x 16 synergy stent, 3. 00 x 16 synergy stent, 2. 25 x 28 synergy stent, 2. 00 mm x 20. 00 mm agent dcb, and opticross hd vascular imaging were used to treat the patient. It was noted that the stents were deployed and no issues with any of the devices occurred. Following treatment with the devices, the patients condition descending rapidly due to the intervention, but was noted to not be considered device related. The patient went into pulmonary edema, was intubated, and then ultimately passed away.

• 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: 12925603
• MDR Text Key: 281680842
• Report Number: 2134265-2021-15301
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 7312
• Device Catalogue Number: 7312
• Device Lot Number: 0027824559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/03/2021 Patient Sequence Number: 1

Treatment

035/180/3MM AMPLATZ GUIDEWIRE-BSC; 2.00 MM X 20.00MM AGENT DCB MR-BSC; 2.00MM X 15MM EMERGE BALLOON_BSC; 2.25 X 16 SYNERGY STENT-BSC; 2.25 X 28 SYNERGY STENT-BSC; 2.25MM X 12MM NC EMERGE BALLOON-BSC; 2.50MM X 15MM NC EMERGE BALLOON-BSC; 2.50MM X 15MM NC EMERGE BALLOON-BSC; 3.00 X 16 SYNERGY STENT-BSC; 4.00MM X 6MM NC EMERGE BALLOON-BSC; OPTICROSS HD VASCULAR IMAGING-BSC