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

Model Number	7005
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed, 2.75x20mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.The 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during inflation at 18 atmospheres, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed, 2.75x20mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.The 3.0mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, during inflation at 18 atmospheres, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.Returned product consisted of a quantum maverick balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear 8mm from the tip approximately 10mm long.There is blood present in the inflation lumen, guidewire lumen, and balloon.The balloon is loosely folded.The reported information indicates the device was inflated to 18atm; therefore, there is no indication the device was inflated over rbp.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 8025658
• Report Number: 2134265-2018-62517
• Device Sequence Number: 1434569
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 06/28/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0022320642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1