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

Model Number	7010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon was tightly folded and there was blood in the inner lumen/shaft.Analysis of the tip, balloon, inner/outer shaft, port weld/exit notch and hypotube included microscopic and visual inspection.Inspection revealed numerous kinks in the hypotube and a hypotube fracture located 76.7cm from the tip.The fracture faces were ovalized, suggesting the area had been kinked prior to being separated.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
Reportable based on device analysis completed on 30jan2021.It was reported that shaft kink occurred.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified left coronary artery.A 3.0mm x 12mm quantum maverick was selected for use.However, during procedure, the shaft was kinked.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a shaft separation.

• 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: 11340374
• Report Number: 2134265-2021-01944
• Device Sequence Number: 16987271
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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): 02/17/2021

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: 10/31/2022
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0024695304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60