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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 10/17/2020
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. Analysis of the tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection. Inspection revealed a fracture in the hypotube located 73. 2cm from the tip of the device, and a kink in the hypotube located 77cm from the tip. The fracture faces of the hypotube were ovalized, suggesting the area was kinked prior to becoming separated. Inspection of the rest of the device found no other damage or defects. The reported device kink was confirmed.
 
Event Description
Reportable based on device analysis completed on 16dec2020. It was reported that shaft kink occurred. The 93% stenosed, 13mmx2. 5mm 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 use. However, during procedure, the shaft was kinked at 70cm from the physician's hand. The procedure was completed with another of the same device. There were no patient complications reported and the patient status was stable. However, returned device analysis revealed a shaft detachment.
 
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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 Key11055940
MDR Text Key223173273
Report Number2134265-2020-18332
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 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0024734359
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2019
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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