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	09/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon fracture occurred.The 85% stenosed, 3.5mm x 20mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation; however, the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that balloon fracture occurred.The 85% stenosed, 3.5mm x 20mm target lesion was located in the moderately tortuous and calcified left anterior descending artery.A 3.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation; however, the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
D4 lot number updated from 0024799556 to 0023272440.Expiration date updated from 11/19/2022 to 01/30/2022.H4 device manufacture date updated from 11/20/2019 to 01/31/2019.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 was a complete separation at 83.9cm distal of the strain relief.There was contrast in the inflation lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 10610958
• Report Number: 2134265-2020-12754
• Device Sequence Number: 14133016
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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): 10/29/2020

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: 01/30/2022
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0023272440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/10/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 81