MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MARVEL; CATHETER, GUIDEWIRE

Model Number	2845
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in a severely tortuous and severely calcified mid circumflex artery.A 6f guidezilla ii, an opticross hd and a marvel guidewire were selected for use.During the procedure, it was noted that upon crossing the proximal lesion, the physician felt resistance, then turned off imaging and had to pull out all three devices as a unit.Furthermore, the marvel guidewire or guidezilla could not separate from the opticross.The procedure was completed with the use of a different non-boston scientific device.No patient complications were reported and the patient status was good post procedure.

• Brand Name: MARVEL
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21510676
• Report Number: 2124215-2025-11552
• Device Sequence Number: 20834932
• Product Code: DQX
• UDI-Device Identifier: 08714729887782
• UDI-Public: 08714729887782
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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: 2845
• Device Catalogue Number: 2845
• Device Lot Number: 0033817764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Date Device Manufactured: 04/12/2024
• 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 Sex: Unknown