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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 Problem Deflation Problem (1149)
Patient Problem Cardiac Enzyme Elevation (1838)
Event Date 04/01/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that balloon deflation issues and electrocardiogram (ecg) elevations occurred.The 90% stenosed target lesion was located in the less calcified proximal left anterior descending artery (lad).The 2.50mm x 12mm maverick balloon was advanced to the target lesion and the balloon was inflated.It was noted that inflation was already "jerky" and the balloon opened suddenly at 14 bar.When attempting to deflate the balloon, it was not possible.As the proximal lad was closed, elevations were noted in the ecg.The proximal end of the balloon catheter was then cut and a guideliner was advanced to aid in deflating the balloon.With the help of the guideliner, the balloon could be partially deflated.The maverick balloon and guideliner were then withdrawn together into a non bsc guide catheter and out of the vessel.The proximal lad had been closed for two to three minutes.Upon removal of the devices, the patient's condition became stable again and the procedure was completed.No additional patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
 
Event Description
It was reported that balloon deflation issues and electrocardiogram (ecg) elevations occurred.The 90% stenosed target lesion was located in the less calcified proximal left anterior descending artery (lad).The 2.50mm x 12mm maverick balloon was advanced to the target lesion and the balloon was inflated.It was noted that inflation was already "jerky" and the balloon opened suddenly at 14 bar.When attempting to deflate the balloon, it was not possible.As the proximal lad was closed, elevations were noted in the ecg.The proximal end of the balloon catheter was then cut and a guideliner was advanced to aid in deflating the balloon.With the help of the guideliner, the balloon could be partially deflated.The maverick balloon and guideliner were then withdrawn together into a non bsc guide catheter and out of the vessel.The proximal lad had been closed for two to three minutes.Upon removal of the devices, the patient's condition became stable again and the procedure was completed.No additional patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 5.6cm distal of the strain relief.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The outer shaft was stretched down for 2mm starting 2mm distal of the exit notch.An unknown guidewire, a guide catheter, and a 6f guide liner were with the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there would have been difficulty deflating the balloon.
 
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Brand Name
MAVERICK
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10013203
MDR Text Key189693278
Report Number2134265-2020-05568
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729369981
UDI-Public08714729369981
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,foreig
Type of Report Initial,Followup
Report Date 06/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/20/2022
Device Model Number7580
Device Catalogue Number7580
Device Lot Number0024806900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2020
Date Manufacturer Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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