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

Model Number	7015
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in left anterior descending artery.A 2.5mm x 15mm fg quantum maverick balloon catheter was advanced for dilation.However, during the procedure, it was noted that the shaft was kinked and was fractured.The procedure was completed with a different device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 55.1cm from the strain relief.There were numerous kinks to the hypotube and shaft of the device.There was contrast in the inflation lumen, blood in the guidewire lumen, and the balloon was tightly folded.Media depicted a portion of the device of which shows a hypotube kink and a separation as well as the devices tyvek and outer box packaging confirming the reported events.
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in left anterior descending artery.A 2.5mm x 15mm fg quantum maverick balloon catheter was advanced for dilation.However, during the procedure, it was noted that the shaft was kinked and was fractured.The procedure was completed with a different 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18130192
• Report Number: 2124215-2023-62783
• Device Sequence Number: 7790461
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 03/08/2026
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0031195011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 64 KG