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

Model Number	2745
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the moderately tortuous and calcified distal right coronary artery (rca).Post atherectomy and stent placement, a 300cm mailman guidewire was advanced to continue the procedure.When the wire was in the rca, it was noticed under fluoroscopy that the tip had broken.No attempt was made to retrieve the device fragment and the detached portion of the device was left in distal rca.There were no patient complications and the patient status was stable.

• 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: 12805677
• Report Number: 2134265-2021-14240
• Device Sequence Number: 14646988
• Product Code: DQX
• UDI-Device Identifier: 08714729188162
• UDI-Public: 08714729188162
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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: 03/24/2022
• Device Model Number: 2745
• Device Catalogue Number: 2745
• Device Lot Number: 0025401963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White