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	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The eccentric target lesion with a bend of between 45 and 90 degrees was located in the left anterior descending artery.A 3.0mm x 8mm quantum maverick balloon catheter was advanced but failed to cross the lesion.When the physician attempted to inflate the balloon, the balloon ruptured.Dilatation was then performed with another balloon and after multiple inflations, a stent was implanted and the procedure was completed.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: 7961036
• Report Number: 2134265-2018-61842
• Device Sequence Number: 11134772
• Product Code: LOX
• UDI-Device Identifier: 08714729392569
• UDI-Public: 08714729392569
• 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
• Report Date (Section B): 10/12/2018

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: 10/13/2020
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0021258505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR