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

Model Number	7015
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified middle of left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the middle of the delivery shaft was fractured and the fractured point was still outside the patient's body.The device was simply pulled out and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified middle of left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, it was noted that the middle of the delivery shaft was fractured and the fractured point was still outside the patient's body.The device was simply pulled out and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
A2: age at time of event - 18 years or older.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 68.1cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.

• 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: 10919198
• Report Number: 2134265-2020-16365
• Device Sequence Number: 19449262
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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): 01/05/2021

1 Device 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: 10/28/2022
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0024673119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No