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

Model Number	2735
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch# (b)(4) that guidewire tip detachment occurred.The target lesion was located in the right atrium.During pacemaker lead addition and generator change procedure, the physician encountered difficulties in positioning the left ventricular (lv) lead in appropriate branch.Several guidewire exchanges occurred to engage the proper position.It was observed that the 182cm mag j mailman guidewire distal tip broke off and was in the vasculature around the coronary sinus.An attempt to remove the device fragment was made but guidewire tip was not retrievable without performing open heart surgery.It was recommended that the detached distal tip remain inside the patient at this time but there was a risk of embolization.It was explained that magnetic resonance imaging (mri) is not recommended with mailman guidewire and the pacemaker.The patient was referred to another cardiologist or computed tomography surgeon for a second opinion for treatment for the detached distal guidewire tip.The procedure was completed with a new lv lead and another luge wire.No patient complications were reported.

• Brand Name: MAILMAN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11732305
• Report Number: 2134265-2021-05068
• Device Sequence Number: 4027257
• Product Code: DQX
• UDI-Device Identifier: 08714729877196
• UDI-Public: 08714729877196
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 08/15/2021
• Device Model Number: 2735
• Device Catalogue Number: 2735
• Device Lot Number: 0024281310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/27/2021
• 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: Other; Required Intervention
• Patient Age: 69 YR