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

Model Number	7005
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the distal end of the left circumflex artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, it was noted that the delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick mr balloon catheter.The balloon was tightly folded with blood in the wire lumen.The batch number on the hub of the device was 22229980.The tip, balloon, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed a hypotube fracture located 52.5 cm from the hub, and numerous kinks in the hypotube.The fracture faces of the separated ends were oval, is if kinked prior to separating.Inspection of the rest of the device found no damage or defects.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the distal end of the left circumflex artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, it was noted that the delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick mr balloon catheter.The balloon was tightly folded with blood in the wire lumen.The batch number on the hub of the device was 22229980.The tip, balloon, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed a hypotube fracture located 52.5 cm from the hub, and numerous kinks in the hypotube.The fracture faces of the separated ends were oval, is if kinked prior to separating.Inspection of the rest of the device found no damage or defects.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the distal end of the left circumflex artery.A 2.75mm x 8mm quantum maverick balloon catheter was advanced for dilation.However, it was noted that the delivery shaft was fractured.The procedure was completed with another of the same device.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: 8416316
• Report Number: 2134265-2019-02302
• Device Sequence Number: 13914769
• Product Code: LOX
• UDI-Device Identifier: 08714729392552
• UDI-Public: 08714729392552
• 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): 05/13/2019

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: 06/08/2021
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0022229980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 04/19/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/09/2019; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 60