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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 7585
Device Problem Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2022
Event Type  malfunction  
Manufacturer Narrative
Returned product consisted of a maverick 2mr balloon catheter. The device was visually and microscopically examined. There were numerous kinks to the hypotube of the device. There was blood in contrast in the inflation lumen and the balloon. There was blood in the guidewire lumen and the balloon was loosely folded. The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device. There was a pinhole in the balloon located 19mm from the tip of the device. The device failed to inflate to rbp. Product analysis could not confirm the reported event as the clinical circumstances could not be replicated. There were unreported numerous kinks to the device and a pinhole to the balloon which is consistent to damage caused by advancing the catheter and likely due to an interaction with lesion characteristics.
 
Event Description
Reportable based on device analysis completed on 28-mar-2022. It was reported that advancing difficulties were encountered. The target lesion was located in the left circumflex artery. A 2. 00mm x 15mm maverick balloon catheter was selected for use but failed to advance during the procedure. The device was removed and the procedure was completed with a different device. There were no patient complications nor injuries reported. However, returned device analysis revealed balloon pinhole.
 
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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 Key14016431
MDR Text Key288663005
Report Number2134265-2022-03893
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7585
Device Catalogue Number7585
Device Lot Number0026314709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2020
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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