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	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the distal end of the left circumflex artery.A 2.5mm x 12mm quantum maverick balloon catheter was selected for use; however, during procedure, the delivery shaft was fractured from the middle to distal end.The device was completely removed without problem.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the distal end of the left circumflex artery.A 2.5mm x 12mm quantum maverick balloon catheter was selected for use; however, during procedure, the delivery shaft was fractured from the middle to distal end.The device was completely removed without problem.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
Age at time of event: patient is 18 year or older.Device evaluation by mfr.: returned product consisted of a quantum maverick mr balloon catheter in two pieces.The balloon was tightly folded.Analysis of the tip, balloon, markerband, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube located 45.4cm from the tip of the device.The fracture faces were ovalized, as if kinked prior to becoming separated.Inspection of the rest of the device found no other damage or defect.

• 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: 10224492
• Report Number: 2134265-2020-08145
• Device Sequence Number: 3194917
• Product Code: LOX
• UDI-Device Identifier: 08714729392651
• UDI-Public: 08714729392651
• 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): 08/21/2020

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: 06/03/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0023894371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1