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

Model Number	H74938931010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, such as if the device was able to be fully retrieved from the patient, but further information was unable to be obtained.
Event or Problem Description
It was reported that guidewire fracture occurred.A pt2 light support 185cm straight guidewire was selected for use; however, during unpacking, the guidewire was found to be fractured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable following the procedure.
Additional Manufacturer Narrative
B5.Describe event or problem updated.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, such as if the device was able to be fully retrieved from the patient, but further information was unable to be obtained.
Event or Problem Description
It was reported that guidewire fracture occurred.A pt2 light support 185cm straight guidewire was selected for use; however, during unpacking, the guidewire was found to be fractured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable following the procedure.It was further reported that the target lesion was 70% stenosed, moderately tortuous and moderately calcified.The device was completely removed from the patient.
Event or Problem Description
It was reported that guidewire fracture occurred.A pt2 light support 18 5cm straight guidewire was selected for use.However, during unpacking, the guidewire was found to be fractured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable following the procedure.It was further reported that the target lesion was 70% stenosed, moderately tortuous and moderately calcified.The device was completely removed from the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: a pt2 light support 185 cm straight guidewire was returned for analysis.The unit was returned with its original box overall visual inspection did not identify failures or evidence that could be lost due to decontamination process.A visual inspection identified the body of the guidewire was kinked.Kinks were found on the device.However, no further issues were noted.The complaint of fracture was not confirmed.

• Brand Name: PT?
• 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: 21785335
• Report Number: 2124215-2025-19927
• Device Sequence Number: 8463296
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: (01)08714729471103(17)260827(10)34729963
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2026
• Device Model Number: H74938931010
• Device Catalogue Number: H74938931010
• Device Lot Number: 0034729963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/30/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG