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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 05/16/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter in two pieces. The balloon was tightly folded. There was blood in the inner lumen/shaft. Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection. Inspection revealed a kink in the hypotube located 61. 5cm form the tip and a complete fracture in the hypotube located 72. 5cm from the tip. The fracture faces of the separated were ovalized, as if kinked prior to being separated. Inspection of the rest of the device found no other damage or defect.
 
Event Description
Reportable based on device analysis completed on 22jul2020. It was reported that shaft kink occurred. The 93% stenosed, 13mmx2. 5mm target lesion was located in the moderately tortuous and calcified left anterior descending artery. A 2. 5mm x 12mm quantum maverick balloon catheter was advanced; however, the balloon delivery shaft was kinked. The procedure was completed with another of same device. No patient complications were reported and the patient was stable. However, returned device analysis revealed shaft 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 Key10398314
MDR Text Key202612258
Report Number2134265-2020-11036
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 08/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0024189545
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2019
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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