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

Model Number	7010
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 12-oct-2018.It was reported that crossing difficulties were encountered.Device evaluated by manufacturer: the target lesion was located in the seriously calcified mid left anterior descending artery.A 3.75mm x 12mm quantum maverick balloon catheter was advanced but unable to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break that could go into the patient's body.The device was returned for analysis.Returned product consisted of a quantum maverick balloon catheter.The returned device separated upon unpacking when received.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated at 53.3cm from the hub and appeared to be kinked prior to separation.There are multiple kinks along the whole device.Microscopic examination revealed that the tip is damaged.There is contrast present in the inflation lumen and balloon.There is blood present in the guidewire lumen and the balloon is loose.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: 8028803
• Report Number: 2134265-2018-62537
• Device Sequence Number: 203106
• Product Code: LOX
• UDI-Device Identifier: 08714729392705
• UDI-Public: 08714729392705
• 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
• Report Date (Section B): 11/01/2018

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: 05/17/2020
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0020663867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 62