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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
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
 
Event or Problem Description
It was reported that shaft break occurred.A 3.25mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, it was noted that the shaft was found fractured.There were no other information provided.
 
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Brand Name
QUANTUM MAVERICK
Common Device Name
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12573239
Report Number2134265-2021-12413
Device Sequence Number16374751
Product Code LOX
UDI-Device Identifier08714729392682
UDI-Public08714729392682
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
P860019
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/06/2023
Device Model Number7010
Device Catalogue Number7010
Device Lot Number0025819442
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/22/2021
Initial Report FDA Received Date10/04/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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