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

Model Number	7005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed, 10 mm x 4 mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 4.0 mm x 8 mm quantum maverick balloon catheter was advanced for dilatation.However, the delivery shaft was fractured 60 cm from the distal end of the balloon.The device was completely removed and 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 device consisted of a quantum maverick balloon catheter in two pieces.The balloon was tightly folded, and there was blood in the wire lumen.The tip, balloon, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed numerous kinks in the hypotube and a complete separation in the hypotube located 72.2cm from the tip of the device.The fracture faces of the separated ends were oval, as if kinked prior to separating.The rest of the device was inspected, and no other damage or irregularities were found.
Event or Problem Description
It was reported that shaft break occurred.The 75% stenosed, 10mmx4mm target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 4.0mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, the delivery shaft was fractured 60cm from the distal end of the balloon.The device was completely removed and 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: 8722160
• Report Number: 2134265-2019-06396
• Device Sequence Number: 2003891
• Product Code: LOX
• UDI-Device Identifier: 08714729392606
• UDI-Public: 08714729392606
• 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): 07/29/2019

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: 01/13/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0023181008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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: 65