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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.Date of event: the date of the event is unknown.Boston scientific became aware of the event on (b)(6) 2021.Therefore a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.
 
Event Description
It was reported that surgical intervention occurred.During a procedure a boston scientific balloon device became loose and was noted to have been roaming around the heart freely.The patient was sent for open heart surgery to remove the balloon device.The procedure was completed and no further patient complications were reported in relation to this event.
 
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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
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 Key11457727
MDR Text Key239095941
Report Number2134265-2021-03158
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,health
Type of Report Initial
Report Date 03/10/2021
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/15/2021
Initial Date FDA Received03/10/2021
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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