MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAILMAN; WIRE, GUIDE, CATHETER

Model Number	2745
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch 5104591 that removal difficulty and device detachment occurred.During a procedure involving a 300xm mailman guide wire, five stents were placed overlapping from the proximal through mid circumflex artery into the first obtuse marginal branch (om).Angiographic result was satisfactory but while trying to remove the mailman, significant resistance was encountered.A portion of the wire sheared off and was retained from the om3 into the proximal aorta.Multiple attempts were made to snare and remove the wire but they were unsuccessful.

• Brand Name: MAILMAN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12806872
• Report Number: 2134265-2021-14292
• Device Sequence Number: 17337843
• Product Code: DQX
• UDI-Device Identifier: 08714729188162
• UDI-Public: 08714729188162
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 01/15/2023
• Device Model Number: 2745
• Device Catalogue Number: 2745
• Device Lot Number: 0026643206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• 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