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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 7015
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 10/14/2020
Event Type  malfunction  
Event Description
It was reported that the label was incorrect.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, it was noticed that the device model was incorrect.There were no patient complications and the patient was stable.
 
Event Description
It was reported that the label was incorrect.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, it was noticed that the device model was incorrect.There were no patient complications and the patient was stable.It was further reported that the stent was shorter than the estimated lesion.
 
Manufacturer Narrative
Updated b5: describe event or problem.
 
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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 Key10774257
MDR Text Key214341975
Report Number2134265-2020-14935
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392767
UDI-Public08714729392767
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,distri
Type of Report Initial,Followup
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/20/2022
Device Model Number7015
Device Catalogue Number7015
Device Lot Number0024628860
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/14/2020
Initial Date FDA Received11/02/2020
Supplement Dates Manufacturer Received10/19/2020
Supplement Dates FDA Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age77 YR
Patient Weight68
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