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

Model Number	2735
Medical Device Problem Codes	Difficult to Remove (1528); Material Too Rigid or Stiff (1544); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm (5pk) mailman guidewire was placed into a mild tortuous diagonal coronary vessel during a bifurcation stenting procedure.Guidewire appeared to be stiff and acute bend on tip was formed to aid its passage.When the guidewire was withdrawn, the radiopaque tip was left in situ.The detached tip/piece was retrieved using a snare device, and the procedure was completed with another device of the same model.The patient was transferred to a larger nearby hospital for a ct scan and overnight observation.Patient was discharged after overnight stay.There was no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of the mailman guidewire batch 33145135 device.During product analysis it was observed that the spring tip was detached and did not return for analysis.No issues could be found that can be attributable to the reported issue of guidewire flexibility problem.The device performed as intended and no evidence of a flexibility issue could be found.
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 182cm (5pk) mailman guidewire was placed into a mild tortuous diagonal coronary vessel during a bifurcation stenting procedure.Guidewire appeared to be stiff and acute bend on tip was formed to aid its passage.When the guidewire was withdrawn, the radiopaque tip was left in situ.The detached tip/piece was retrieved using a snare device, and the procedure was completed with another device of the same model.The patient was transferred to a larger nearby hospital for a ct scan and overnight observation.Patient was discharged after overnight stay.There was no patient complications reported.

• Brand Name: MAILMAN
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20854309
• Report Number: 2124215-2024-76862
• Device Sequence Number: 8839356
• Product Code: DQX
• UDI-Device Identifier: 08714729165712
• UDI-Public: 08714729165712
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 01/03/2026
• Device Model Number: 2735
• Device Catalogue Number: 2735
• Device Lot Number: 0033145135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown