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	03/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed, 4.0x15mm target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 4.0mm x 15mm quantum maverick balloon catheter was selected for use to dilate the lesion.However, the shaft was fractured and it could not enter to patient's body.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 85% stenosed, 4.0x15mm target lesion was located in the moderately tortuous and severely calcified left circumflex artery.A 4.0mm x 15mm quantum maverick balloon catheter was selected for use to dilate the lesion.However, the shaft was fractured and it could not enter to patient's body.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.: received product consisted of a quantum maverick balloon catheter in two pieces.The balloon was tightly folded with blood in the wire lumen (shaft), inflation lumen (shaft) and balloon.The hypotube, inner/outer shafts, balloon and tip were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube, hypotube fracture located 23 cm from the strain relief, and tip damage.The fracture faces of the separated hypotube were ovalized, as if kinked prior to separating.Inspection of the rest of the device found no other damage.

• 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: 8556015
• Report Number: 2134265-2019-04411
• Device Sequence Number: 11327694
• Product Code: LOX
• UDI-Device Identifier: 08714729392828
• UDI-Public: 08714729392828
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 10/29/2021
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0022863063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 72