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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 7212
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2020
Event Type  Injury  
Event Description
It was reported that shaft break occurred.The target lesion was located in a calcified vessel.A 2.50 x 12 synergy drug-eluting stent was deployed in a kissing stent fashion.The stent was deployed well but somehow became stuck underneath the other stent that was already placed and got pinned up against a stent strut and snapped off the hypotube of the stent balloon.A 3.50mm x 12mm nc emerge balloon catheter was then advanced, but was also pinned within the stent strut and snapped off as well.They used a snare to remove the device and patient was stable enough to move to intensive care unit (icu).
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 108cm distal of the strain relief.Distal portion of the device was missing.Separation was at the midshaft bond.The outer shaft at the midshaft bond was stretched down.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the shaft was separated.
 
Event Description
It was reported that shaft break occurred.The target lesion was located in a calcified vessel.A 2.50 x 12 synergy drug-eluting stent was deployed in a kissing stent fashion.The stent was deployed well but somehow became stuck underneath the other stent that was already placed and got pinned up against a stent strut and snapped off the hypotube of the stent balloon.A 3.50mm x 12mm nc emerge balloon catheter was then advanced, but was also pinned within the stent strut and snapped off as well.They used a snare to remove the device and patient was stable enough to move to icu.
 
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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 Key10323610
MDR Text Key200383594
Report Number2134265-2020-09195
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K141236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7212
Device Catalogue Number7212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Date Manufacturer Received08/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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