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

Model Number	2841
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire detachment occurred.The 90% stenosed target lesion was located in the mildly tortuous and calcified proximal artery.A 300cm marvel guidewire was advanced and angioplasty and stenting was performed.Upon removal of the guidewire, it was noticed that the distal wire tip was left in the proximal artery.Another stent was implanted to hold the wire fragment into the artery wall so that it would not migrate.The procedure was completed successfully and there were no patient complications reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19988496
• Report Number: 2124215-2024-47826
• Device Sequence Number: 7075857
• Product Code: DQX
• UDI-Device Identifier: 08714729881193
• UDI-Public: 08714729881193
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2841
• Device Catalogue Number: 2841
• Device Lot Number: 0033071337
• 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: 07/23/2024
• Initial Report FDA Received Date: 08/14/2024
• Date Device Manufactured: 12/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown