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

Model Number	7015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.25mm x 15mm quantum maverick balloon catheter was selected for use.It was noted that there was a kink at the proximal end of the delivery shaft.High resistance was encountered when the physician inserted the device and upon withdrawal, it was noted that the shaft was fractured.The procedure was completed with another 3.25mm x 15mm quantum maverick balloon catheter.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.A 3.25mm x 15mm quantum maverick balloon catheter was selected for use.It was noted that there was a kink at the proximal end of the delivery shaft.High resistance was encountered when the physician inserted the device and upon withdrawal, it was noted that the shaft was fractured.The procedure was completed with another 3.25mm x 15mm quantum maverick balloon catheter.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.The balloon was loosely folded and there are multiple kinks in the shaft.The tip and exit notch is damaged.The shaft is broken 96.3cm from the hub.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: 7776485
• Report Number: 2134265-2018-60069
• Device Sequence Number: 1319559
• Product Code: LOX
• UDI-Device Identifier: 08714729392798
• UDI-Public: 08714729392798
• 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): 10/03/2018

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: 09/13/2020
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0021137673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1