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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7314
Device Problem Material Deformation (2976)
Patient Problem Vascular Dissection (3160)
Event Date 11/23/2018
Event Type  Injury  
Event Description
It was reported that vessel dissection occurred.The target lesion was located in a vein graft supplying the mid and proximal right coronary artery with a non-bsc previously implanted stent.After a 1.50mm rotalink plus was advanced and initially burred the lesion, the physician decided to upsize the burr to 2.00mm rotalink burr; however, no burring effect was noted.Subsequently, a 10/2.50 flextome cutting balloon was advanced to the mid lesion and was then inflated at 1 atmospheres (atm) per second.The physician left it at 12 atm for 20 seconds and deflated for 30 seconds.The same action was performed on the proximal lesion using another 10/2.50 flextome cutting balloon.However, it still had no effect in "cracking" the lesion.Thus, a 5.00mm x 20mm nc emerge balloon catheter was advanced to the mid lesion and inflated at 18 atm for 30 seconds.A "dog boning" effect was observed from the center and the vessel seemed to open.The physician deflated the balloon and positioned it to the proximal lesion.Consequently, while the balloon was inflated again at 18 atm, the physician noticed leaking contrast and stated that dissection had occurred.The physician then implanted 3 covered stents which ceased the bleeding.No further patient complications were reported that the patient's status was stable.
 
Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 10:54 am ct.The report number is being corrected from: 2134265-2018-64224 to: 2134265-2018-63304.
 
Event Description
It was reported that vessel dissection occurred.The target lesion was located in a vein graft supplying the mid and proximal right coronary artery with a non-bsc previously implanted stent.After a 1.50mm rotalink plus was advanced and initially burred the lesion, the physician decided to upsize the burr to 2.00mm rotalink burr; however, no burring effect was noted.Subsequently, a 10/2.50 flextome cutting balloon was advanced to the mid lesion and was then inflated at 1 atmospheres (atm) per second.The physician left it at 12 atm for 20 seconds and deflated for 30 seconds.The same action was performed on the proximal lesion using another 10/2.50 flextome cutting balloon.However, it still had no effect in "cracking" the lesion.Thus, a 5.00mm x 20mm nc emerge balloon catheter was advanced to the mid lesion and inflated at 18 atm for 30 seconds.A "dog boning" effect was observed from the center and the vessel seemed to open.The physician deflated the balloon and positioned it to the proximal lesion.Consequently, while the balloon was inflated again at 18 atm, the physician noticed leaking contrast and stated that dissection had occurred.The physician then implanted 3 covered stents which ceased the bleeding.No further patient complications were reported that the patient's status was stable.It was further reported that the target lesion was mildly tortuous and moderately calcified.Only one 10/2.50 flextome cutting balloon used during the procedure which was advanced to both mid and proximal lesions.The grade of dissection was not flow limiting with timi 3 flow.# non-bsc stent were used to fix the dissection.
 
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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
MDR Report Key8110976
MDR Text Key128608849
Report Number2134265-2018-63304
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/21/2019
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
Device Operator Health Professional
Device Expiration Date06/04/2020
Device Model Number7314
Device Catalogue Number7314
Device Lot Number0022206571
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2018
Initial Date FDA Received11/28/2018
Supplement Dates Manufacturer Received11/28/2018
Supplement Dates FDA Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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