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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 Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Returned product consisted of a quantum maverick balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. The balloon was tightly folded. There were numerous hypotube kinks throughout the device. There was a complete hypotube separation 48cm distal of the strain relief. The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 20-may-2019. It was reported that shaft kink occurred. The target lesion was located in the right coronary artery. A 2. 5mmx 15mm quantum maverick balloon catheter was used but shaft kink was noted. The procedure was completed with another of the same device. No patient complications were reported and patient status was stable. However, returned device analysis revealed a hypotube separation.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8695874
MDR Text Key147896912
Report Number2134265-2019-06879
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
Report Date 06/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2022
Device Model Number7015
Device Catalogue Number7015
Device Lot Number0023188868
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2019
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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