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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
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/01/2021
Event Type  Injury  
Event Description
It was reported that balloon detachment occurred. Following rotational atherectomy during a complex percutaneous coronary intervention, the physician attempted to use a 4. 00 x 10mm wolverine cutting balloon. The wolverine got stuck in the vessel and during a removal attempt, the device separated leaving the balloon and blades behind. The doctor then tried to cross past the lesion and the wolverine fragment with an emerge balloon. The emerge balloon also got stuck and separated from its catheter. The patient is stable at this time.
 
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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
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12000182
MDR Text Key256236835
Report Number2134265-2021-07716
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2021
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 Treatment Data
Date Received: 06/15/2021 Patient Sequence Number: 1
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