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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 7005
Device Problems Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2019
Event Type  malfunction  
Event Description
It was reported that balloon pinhole occurred. The target lesion was located in the left anterior descending artery. A 3. 0mm x 8mm quantum maverick balloon catheter was advanced to the distal end of the lesion by a guidezilla guide extension catheter. However, it was noted that the balloon could not be filled normally and the contrast agent was found to be leaking. The balloon was damaged and a visible pinhole was noted. There were no patient complications reported and the patient was stable.
 
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Brand NameQUANTUM MAVERICK
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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9152015
MDR Text Key161712549
Report Number2134265-2019-11953
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2021
Device Model Number7005
Device Catalogue Number7005
Device Lot Number0023083228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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