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	04/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 24mm x 2.75mm taget lesion was located in the severely tortuous and calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, the delivery shaft fractured.The procedure was completed with another of the same device.No patient serious injury nor complications were reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 24mm x 2.75mm taget lesion was located in the severely tortuous and calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, the delivery shaft fractured.The procedure was completed with another of the same device.No patient serious injury nor complications were reported and the patient status was stable.It was further reported that the physician used the second balloon to removed the first device out on the patient's body together.
Additional Manufacturer Narrative
Adverse event/product problem, outcomes attrib to adv event and type of reportable event updated.The quantum maverick was returned for analysis.The balloon was loosely folded with blood in the wire lumen (inner shaft).The balloon, proximal weld, inner/outer shaft were microscopically and visually inspected.Inspection revealed a separation in the hypotube located 22.5cm from the strain relief with numerous kinks in the hypotube.The fracture faces of the hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 24mm x 2.75mm taget lesion was located in the severely tortuous and calcified left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, the delivery shaft fractured.The device was completely removed from the patient's body and the procedure was completed with another balloon.No patient serious injury nor complications were reported and the patient status was stable.
Additional Manufacturer Narrative
The quantum maverick was returned for analysis.The balloon was loosely folded with blood in the wire lumen (inner shaft).The balloon, proximal weld, inner/outer shaft were microscopically and visually inspected.Inspection revealed a separation in the hypotube located 22.5cm from the strain relief with numerous kinks in the hypotube.The fracture faces of the hypotube were ovalized, as if kinked prior to separating.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: 8587852
• Report Number: 2134265-2019-04913
• Device Sequence Number: 11147351
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• 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): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0023349608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 05/22/2019; 06/03/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/13/2019; 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 78