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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 7005
Device Problems Material Puncture/Hole (1504); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2019
Event Type  malfunction  
Event Description
It was reported that balloon pinhole occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced to the distal end of the lesion by a guidezilla guide extension catheter.However, it was noted that the balloon could not be filled normally and the contrast agent was found to be leaking.The balloon was damaged and a visible pinhole was noted.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that balloon pinhole occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced to the distal end of the lesion by a guidezilla guide extension catheter.However, it was noted that the balloon could not be filled normally and the contrast agent was found to be leaking.The balloon was damaged and a visible pinhole was noted.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.No leaks were detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported balloon ruptured.
 
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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 Key9152015
MDR Text Key161712549
Report Number2134265-2019-11953
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392569
UDI-Public08714729392569
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 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/13/2021
Device Model Number7005
Device Catalogue Number7005
Device Lot Number0023083228
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2019
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE EXTENSION CATHETER: GUIDEZILLA; GUIDE EXTENSION CATHETER: GUIDEZILLA
Patient Age68 YR
Patient Weight66
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