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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7010
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for post-dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No known patient complications nor injuries reported.
 
Event Description
It was reported that balloon rupture occurred.A 3.0mm x 12mm quantum maverick balloon catheter was advanced for post-dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No known patient complications nor injuries reported.It was further reported that the 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.The balloon ruptured during third inflation at 12 atmospheres for 5 seconds.There were no patient complications nor injuries reported and the patient's status was fine.
 
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Brand Name
QUANTUM MAVERICK
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10475016
MDR Text Key205090577
Report Number2134265-2020-12075
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392675
UDI-Public08714729392675
Combination Product (y/n)N
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/06/2023
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0025316960
Was Device Available for Evaluation? No
Date Manufacturer Received10/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
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