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	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date as event date not provided.
Event or Problem Description
It was reported distal tip detachment occurred and the device was retrieved.The target lesion was located in the circumflex artery.A 190cm, straight-tip marvel guidewire was selected for use.However, during the procedure, it was noted that the guidewire tip broke off while attempting to cross the lesion.The device was retrieved from the patient and no product was left in the patient's body.There were no patient complications nor injuries reported.

• Brand Name: MARVEL
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10726250
• Report Number: 2134265-2020-14650
• Device Sequence Number: 3433155
• Product Code: DQX
• UDI-Device Identifier: 08714729887782
• UDI-Public: 08714729887782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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 Expiration Date: 06/16/2023
• Device Model Number: 2845
• Device Catalogue Number: 2845
• Device Lot Number: 0025606688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention