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

Model Number	2845
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment and an unretrieved device fragment occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 190cm straight-tip (pouch) marvel guidewire was selected for use.It was noted that the difficult lesion had a calcific ledge.During the procedure, the inserted guidewire became stuck in the calcium upon retraction.The guidewire, non-boston scientific (bsc) balloon, and non-bsc guide extender were pulled back simultaneously as one unit by the physician.However, upon full removal of the guidewire, it was noted that approximately 1 centimeter of the distal tip had broken off and was seen in a distal branch of the vessel.Snaring was attempted but failed due to the inability to cross the lesion, and the fragment of the device was left in the patient.Another retrieval attempt will be made when the patient is brought back for further treatment.The patient fully recovered.

• 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: 19234433
• Report Number: 2124215-2024-24157
• Device Sequence Number: 6732979
• Product Code: DQX
• UDI-Device Identifier: 08714729887782
• UDI-Public: 08714729887782
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/02/2024

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: 2845
• Device Catalogue Number: 2845
• Device Lot Number: 0033250255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown