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

Model Number	7590
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to cross the lesion and burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient condition was good.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to cross the lesion and burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient condition was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.The hypotube of the device had numerous kinks.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located on the proximal end of the markerband.The device failed to inflate to rbp.Analysis could not confirm the reported crossing difficulties, which could not be confirmed because the clinical circumstances could not be replicated.However, there were unreported hypotube kinks to the device, which could cause resistance upon device advancement.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16303388
• Report Number: 2124215-2023-04470
• Device Sequence Number: 17843228
• Product Code: LOX
• UDI-Device Identifier: 08714729370154
• UDI-Public: 08714729370154
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2025
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0030011501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown