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

Model Number	7010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, concentric and the de novo target lesion was located in the severely tortuous and moderately calcified right coronary artery.After a jr 3.5 non-bsc guide catheter was engaged and a non-bsc guide wire crossed the lesion.A 2.0mm x 12mm quantum maverick balloon catheter was advanced for pre-dilation; however, upon inflation at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The balloon was loosely folded with fluid in the inflation lumen, and bloody on the outside.The tip, balloon, markerbands, proximal weld, inner/outer shaft (lumen) were microscopically and visually inspected.Inspection found no damage or irregularities.Functional testing of the device was done by attaching an inflation device (filled with water) to the hub of the catheter and applying positive pressure.The balloon was inflated to 20 atms and held inflation for 5 minutes without leaking or losing pressure.The reported burst was not confirmed.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 90% stenosed, concentric and the de novo target lesion was located in the severely tortuous and moderately calcified right coronary artery.After a jr 3.5 non-bsc guide catheter was engaged and a non-bsc guide wire crossed the lesion.A 2.0mm x 12mm quantum maverick balloon catheter was advanced for pre-dilation; however, upon inflation at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status 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: 8334023
• Report Number: 2134265-2019-01192
• Device Sequence Number: 16156622
• Product Code: LOX
• UDI-Device Identifier: 08714729392637
• UDI-Public: 08714729392637
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/02/2019

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: 02/12/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0021737075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR