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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 Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2019
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon catheter and guide wire were locked and were unable to remove.The devices were then removed together and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: received product consisted of a quantum maverick balloon catheter.The balloon was tightly folded with blood in the wire lumen.The blood in the wire lumen (inner shaft) was removed by soaking in a warm water bath with ultrasonic cleaning for 1 hour.The hypotube, inner/outer shafts, balloon and tip were microscopically and visually inspected.Inspection found no damage or irregularities with the returned device.The guidewire used in the procedure was not returned for analysis, so a.014" test guide wire was used for functional testing.The test wire was loaded into the tip of the quantum maverick and advanced out through the port/exit notch.There were no issues, and the wire performed in the expected fashion.
 
Event Description
It was reported that catheter entrapment occurred.The target lesion was located in a coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, the balloon catheter and guide wire were locked and were unable to remove.The devices were then removed together and the procedure was completed with another of the same device.There were no patient complications reported and the patient 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 Key8583341
MDR Text Key144169743
Report Number2134265-2019-04774
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392781
UDI-Public08714729392781
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 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/15/2022
Device Model Number7015
Device Catalogue Number7015
Device Lot Number0023190016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Date Manufacturer Received05/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient Weight75
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