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

Model Number	7015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately calcified mid-to-distal segment of the left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was selected for dilation.However, after opening the package and pulling out the percutaneous transluminal coronary angioplasty expansion catheter, it was noticed that the delivery catheter was fractured at 56cm from the hub.The device was immediately replaced, and no patient complications were reported.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.A visual inspection revealed that at 50cm from the strain relief, the hypotube was separated.At 49cm from the strain relief, the hypotube was kinked.A microscopic inspection revealed no further damage or irregularity.There was contrast in the inflation lumen and the balloon was tightly folded.A media depicted several photos of a portion of the device noting a separation and a kink to the hypotube of the device confirming the reported event.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the moderately calcified mid-to-distal segment of the left anterior descending artery.A 2.5mm x 15mm quantum maverick balloon catheter was selected for dilation.However, after opening the package and pulling out the percutaneous transluminal coronary angioplasty expansion catheter, it was noticed that the delivery catheter was fractured at 56cm from the hub.The device was immediately replaced, and no patient complications were reported.

• 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: 19229466
• Report Number: 2124215-2024-24159
• Device Sequence Number: 6732820
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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 Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0032601799
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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: Unknown