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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 Consequences Or Impact To Patient (2199)
Event Date 11/29/2019
Event Type  malfunction  
Manufacturer Narrative
Returned product consisted of a quantum maverick balloon catheter. The balloon was loosely folded. There were numerous hypotube kinks. The hypotube was separated 56cm from the hub. The separated ends of the hypotube was ovaled indicating the hypotube was kinked prior to separating.
 
Event Description
Reportable based on device analysis completed on 10jan2020. It was reported that shaft kink occurred. The 92% stenosed, 14mmx2. 4mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. A 2. 5mm x 12mm quantum maverick balloon catheter was advanced for dilatation; however, the balloon delivery shaft was kinked. The procedure was completed with another of the same device. There were no patient complications reported and the patient's status was stable. However, returned device analysis revealed 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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9643454
MDR Text Key178637605
Report Number2134265-2020-00694
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 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/02/2022
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0023584603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2019
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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