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

Model Number	7010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 4.0mm x 12mm quantum maverick balloon catheter was selected for use.However, it was noted that the balloon was broken.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 4.0mm x 12mm quantum maverick balloon catheter was selected for use.However, it was noted that the balloon was broken.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter in two pieces.The device was tightly folded with blood in the wire lumen.Inspection revealed a complete separation in the hypotube located 69.8cm from the tip of the device, and there were numerous kinks in the hypotube.The fracture faces of the separated ends were oval, as if kinked prior to separation.Inspection of the remainder of the device, apart from the observed damage, revealed 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: 8165601
• Report Number: 2134265-2018-64012
• Device Sequence Number: 1997167
• Product Code: LOX
• UDI-Device Identifier: 08714729392712
• UDI-Public: 08714729392712
• 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): 04/24/2019

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: 06/07/2021
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0022225433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 60