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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 Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  Injury  
Event Description
It was reported that a shaft detachment occurred. This 2. 50mm x 12mm maverick balloon catheter was selected for a percutaneous coronary intervention. During removal from the lesion difficulties were encountered and the distal end of the balloon became stuck inside the guide catheter and broke. If was noted that the balloon was deflated prior to removal. No patient complications were reported.
 
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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
pmt 741 persiaran cassia selat
bandarcassia, pulau pinan 14110
MY 14110
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12591886
MDR Text Key275430736
Report Number2134265-2021-12584
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7580
Device Catalogue Number7580
Device Lot Number0026631942
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/07/2021 Patient Sequence Number: 1
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