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	12/02/2019
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 shaft break occurred.After the 3.5mm x 15mm quantum maverick was introduced inside the patient it was noted that the middle and distal end of the balloon delivery shaft were fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.After the 3.5mm x 15mm quantum maverick was introduced inside the patient it was noted that the middle and distal end of the balloon delivery shaft were fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the fracture was near the distal portion of the device and it was completely and simply removed without any intervention performed.
Event or Problem Description
It was reported that shaft break occurred.After the 3.5mm x 15mm quantum maverick was introduced inside the patient it was noted that the middle and distal end of the balloon delivery shaft were fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the fracture was near the distal portion of the device and it was completely and simply removed without any intervention performed.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Lot number corrected to 0023874524 from previously reported 0023808059.Use before date/expiration corrected to 05/29/2022 from previously reported 05/16/2022.Device manufacture date corrected to 05/30/2019 from previously reported 05/17/2019.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The hypotube was separated 76cm from the hub.The separated ends of the hypotube was ovaled indicating the hypotube was kinked prior to separating.There were numerous hypotube kinks.

• 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: 9455620
• Report Number: 2134265-2019-15618
• Device Sequence Number: 3039944
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: 08714729392804
• 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,Followup
• Report Date (Section B): 01/28/2020

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: 05/29/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0023874524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/11/2019; 01/06/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/18/2019; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1