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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7580
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter. The shaft, hypotube, tip and balloon were microscopically and visually examined. There were numerous kinks. There was contrast in the inflation lumen. The balloon was tightly folded. The device was functionally tested with a 0. 014 inch guidewire. The outer shaft was damaged 6mm proximal of the exit notch. Inspection of the remainder of the device presented no other damage or irregularities. Product analysis confirmed the reported difficulty advancing the guidewire.
 
Event Description
It was reported that a balloon device could not be placed onto a wire. During preparation and while outside the patient, a 2. 00mm x 12mm maverick balloon could not be placed onto the wire. The procedure was completed with another of the same device. No patient complications were reported in relation to this event. However, the device was returned and analysis revealed outer shaft damage.
 
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Brand NameMAVERICK
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 Key10742010
MDR Text Key213261018
Report Number2134265-2020-14833
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7580
Device Catalogue Number7580
Device Lot Number0025095998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2020
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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