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

Model Number	7015
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the none calcified and non tortuous mid of left anterior descending artery.Following stent implantation, a 2.5mm x 15mm quantum maverick balloon catheter was advanced for post-dilatation.However, during expansion the physician found the front end of the catheter was broken, 40 cm from the hub but not completely fractured.The device was completely removed in a normal manner and the procedure was successfully completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the none calcified and non tortuous mid of left anterior descending artery.Following stent implantation, a 2.5mm x 15mm quantum maverick balloon catheter was advanced for post-dilatation.However, during expansion the physician found the front end of the catheter was broken, 40 cm from the hub but not completely fractured.The device was completely removed in a normal manner and the procedure was successfully completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.There was a hypotube separation 92.8cm from the strain relief.At 90cm from the strain relief the device was kinked.There was exit notch damage to the device.There was contrast and blood in the inflation lumen and balloon folds.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device.

• 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: 11925803
• Report Number: 2134265-2021-07037
• Device Sequence Number: 13690176
• Product Code: LOX
• UDI-Device Identifier: 08714729392767
• UDI-Public: 08714729392767
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 05/19/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0025521882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR