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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 7015
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2019
Event Type  malfunction  
Event Description
It was reported that tip detachment occurred.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, during introduction, it was noted the distal tip of the device was fractured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a complete separation at 59.4cm distal of the strain relief.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.
 
Event Description
It was reported that tip detachment occurred.A 2.5mm x 15mm quantum maverick balloon catheter was selected for use.However, during introduction, it was noted the distal tip of the device was fractured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
QUANTUM MAVERICK
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9343399
MDR Text Key173451782
Report Number2134265-2019-13991
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392767
UDI-Public08714729392767
Combination Product (y/n)N
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/02/2022
Device Model Number7015
Device Catalogue Number7015
Device Lot Number0023888408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age49 YR
Patient Weight70
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