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

Model Number	7015
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, 21mm x 3.0mm target lesion was located in the severely calcified left coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation but the balloon burst.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, 21mm x 3.0mm target lesion was located in the severely calcified left coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation but the balloon burst.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further reported that the balloon was inflated once and ruptured at 15 atmospheres for 20 seconds.
Additional 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 was contrast in the inflation lumen and 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 were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, 21mm x 3.0mm target lesion was located in the severely calcified left coronary artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation but the balloon burst.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.It was further reported that the balloon was inflated once and ruptured at 15 atmospheres for 20 seconds.

• Brand Name: QUANTUM 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: 11013767
• Report Number: 2134265-2020-17860
• Device Sequence Number: 19737309
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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: 11/11/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024753326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 02/04/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/21/2020; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 63