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

Model Number	7015
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: hospital affiliated to school of medicine, (b)(6).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 kinks 12cm and 14.9cm distal from the strain relief.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 1mm long starting 2mm proximal from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that shaft kink occurred.The target lesion was located in the left circumflex artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon delivery shaft was kinked.The procedure was completed with another of the same device.There were no patient complications and the patient was stable.However, returned device analysis revealed balloon longitudinal tear.

• 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: 11565669
• Report Number: 2134265-2021-03856
• Device Sequence Number: 17355019
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 03/12/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025346537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 78