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

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

Patient Problem Vascular Dissection (3160)

Event Date 06/16/2021

Event Type  Injury  

Event Description

It was reported that vessel dissection occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, 2.75x32mm, concentric, de novo target lesion was located in the mildly calcified right coronary artery.A 1.5x20mm and a 2.25x20mm emerge balloon catheters were used for pre-dilation.However, a vessel dissection was noted.A 2.5x20mm and a 2.75x20mm nc quantum balloon catheters were inflated long enough to recover the dissection.Subsequently, a 2.75x12mm promus elite balloon expandable stent was placed in the proximal right coronary artery.Timi 3 flow was noted.No further complications were reported and the patient status was stable.

• Brand Name: 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: 12122278
• MDR Text Key: 260065521
• Report Number: 2134265-2021-08555
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: GUIDE CATHETER: JR4 6F LUANCHER; GUIDEWIRE: 0.014 LUGE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR