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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the device.There was contrast present in the inflation lumen.The exit notch was torn for a length of 5mm moving distally towards the tip of the device.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device to rated burst pressure.Inflation failed to inflate to burst pressure as the exit notch damage was extended just passed the bonded area and thus exposed the inflation lumen and guidewire lumen for a length of 1mm.Product analysis could not confirm the reported burst, as there was a material tear of the exit notch.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.

• 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: 11971509
• Report Number: 2134265-2021-07493
• Device Sequence Number: 4492110
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 03/12/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025346524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 65