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

Model Number	7005
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 4.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during first inflation, the balloon failed to inflate and a pinhole was noted on the balloon material.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
D4 lot number, d4 expiration date, and h4 device manufacture date: corrected.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 53.6cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported balloon burst.
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 4.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during first inflation, the balloon failed to inflate and a pinhole was noted on the balloon material.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
D4 lot number, d4 expiration date, and h4 device manufacture date: corrected.
Event or Problem Description
It was reported that balloon pinhole occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 4.5mm x 8mm quantum maverick balloon catheter was advanced for dilatation.However, during first inflation, the balloon failed to inflate and a pinhole was noted on the balloon material.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient 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: 10840170
• Report Number: 2134265-2020-15803
• Device Sequence Number: 4142170
• Product Code: LOX
• UDI-Device Identifier: 08714729392613
• UDI-Public: 08714729392613
• 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,Followup
• Report Date (Section B): 12/15/2020

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: 01/07/2023
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0025003804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 12/08/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/07/2020; 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70