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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 Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 02/28/2020
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There were numerous kinks. There was a complete separation at 47. 8cm distal of the strain relief. The balloon was tightly folded. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis confirmed the reported kink.
 
Event Description
Reportable based on device analysis completed on 16 may 2020. It was reported that shaft kink occurred. A 2. 5mm x 12mm quantum maverick balloon catheter was selected for use. However, during unpacking, it was noted that the shaft was kinked. However, returned device analysis revealed shaft detached/ separated.
 
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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 Key10140285
MDR Text Key194765926
Report Number2134265-2020-07835
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392651
UDI-Public08714729392651
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 06/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/20/2022
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0023825479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2019
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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