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	06/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 2.75mm x 12mm target lesion was located in the left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the balloon delivery shaft was fractured.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
D4: batch/lot updated from 0024236532 to 24502626.D4: expiration date updated: from 08/07/2022 to 09/26/2022.Device evaluated by mfr.: returned device consisted of a quantum maverick balloon catheter in two pieces.The balloon was tightly folded.Analysis of the tip, balloon, markerband, inner/outer shaft, hypotube and hub included microscopic and visual inspection.Inspection revealed a fracture in the hypotube located 52.7cm from the tip of the device, and numerous kinks in the hypotube.The fracture faces of the separation were ovalized, suggesting the area was kinked prior to becoming separated.Inspection of the device found no other damage or defects.The reported fracture was confirmed.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 2.75mm x 12mm target lesion was located in the left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the balloon delivery shaft was fractured.The procedure was completed with another of 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: 10254588
• Report Number: 2134265-2020-08481
• Device Sequence Number: 2577707
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• 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): 08/31/2020

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: 09/26/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024502626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 83