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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 7163
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation and it was noted that there was difficulty during delivery.During inflation in a calcified lesion, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation and it was noted that there was difficulty during delivery.During inflation in a calcified lesion, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the patient's condition post procedure was good.
 
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Brand Name
EMERGE
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12405453
MDR Text Key269276749
Report Number2134265-2021-11072
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,distri
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2022
Device Model Number7163
Device Catalogue Number7163
Device Lot Number0024935967
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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