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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7132
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Event Description
It was reported that the device break occurred. A 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal circumflex coronary and diagonal resistant lesion. The physician wired the vessel and attempted to balloon the circumflex. The lesion did not expand. A 1. 50mm rotapro was selected for atherectomy. After two passes, the 1. 50mm rotapro was removed. The physician wired the diagonal lesion. A 1. 25mm rotapro burr was advanced. Atherectomy was performed. A large perforation was noted after using the 1. 25mm rotapro burr. The physician tamponade the vessel with a balloon and a stent was deployed to cover the perforation but it was unable to get to area. The physician repositioned the 2. 00mm x 12mm emerge balloon. There was difficulty removing the balloon. The balloon pulled apart at the distal to the inner connection. The emerge balloon and guidewire were removed together as one unit from the patient. The guidewire was able to be removed from the emerge once outside the patient. The patient died post.
 
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Brand NameEMERGE
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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12459697
MDR Text Key271013210
Report Number2134265-2021-11521
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7132
Device Catalogue Number7132
Device Lot Number0027081921
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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