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

Model Number	7010
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the quantum maverick balloon catheter.The hypotube, shaft, tip, and balloon were microscopically and visually examined.There was blood in the inflation lumen, guidewire lumen, and in the balloon.The balloon was loosely folded.Inspection of the device revealed that there was a pinhole at the distal end of the distal markerband.There was no damage or irregularities to the markerband to have caused the pinhole.
Event or Problem Description
Reportable based on device analysis completed on 13-jan-2021.It was reported that balloon inflation failure occurred.The 85% stenosed target lesion was located in the middle and distal end of left circumflex coronary artery.A 2.75mm x 12mm quantum maverick balloon catheter was used for dilatation but the balloon could not fully inflate.The procedure was completed with another of the same device.There were no complications reported and the patient is stable.However, returned device analysis revealed a balloon pinhole.

• 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: 11239912
• Report Number: 2134265-2021-00434
• Device Sequence Number: 17018803
• 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
• Report Date (Section B): 01/27/2021

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: 09/16/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024442073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1