MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7580
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Cardiac Enzyme Elevation (1838)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem 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the help of the guideliner, the balloon could be partially deflated.The maverick balloon and guideliner were then withdrawn together into a non bsc guide catheter and out of the vessel.The proximal lad had been closed for two to three minutes.Upon removal of the devices, the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 or Problem 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the help of the guideliner, the balloon could be partially deflated.The maverick balloon and guideliner were then withdrawn together into a non bsc guide catheter and out of the vessel.The proximal lad had been closed for two to three minutes.Upon removal of the devices, the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.
Additional 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.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10013203
• Report Number: 2134265-2020-05568
• Device Sequence Number: 14242826
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0024806900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention