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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 7312
Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems Embolism (1829); Stenosis (2263); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 04/24/2020
Event Type  Injury  
Event Description
It was reported that a balloon rupture occurred resulting in removal difficulty, device fracture, no flow, and subsequent bypass surgery. The patient presented with chest pain. Vascular access was obtained via the radial artery. The non-totally occluded, concentric target lesion was located in a non-tortuous and severely calcified left anterior descending artery (lad). A 2. 5 x 10mm wolverine cutting balloon was used for plaque modification before the 3. 0 x 12mm nc emerge balloon catheter was advanced to treat the target lesion. On inflation up to 30 atmospheres, the balloon ruptured and when the physician tried to remove the device, significant resistance was encountered. After several removal attempts, only part of the balloon was removed and a dissection was noted where the balloon had been earlier. The physician attempted to rewire the vessel but was unable to do so due to the dissection. Angiogram revealed a balloon marker was lodged distally. As there was now no flow in the lad, a surgeon was called and the patient underwent coronary artery bypass graft (cabg). The patient was recovering well in stable condition.
 
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Brand NameNC EMERGE
Type of DeviceCATHETERS, 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 Key10111541
MDR Text Key193417965
Report Number2134265-2020-06369
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/09/2021
Device Model Number7312
Device Catalogue Number7312
Device Lot Number0024573755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2019
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: 06/02/2020 Patient Sequence Number: 1
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