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

Model Number	2783
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter facility name - (b)(6) hospital.
Event or Problem Description
It was reported that tip break and cancelled procedure occurred.A 300cm pt2 guidewire was selected for use in a non tortuous 85% stenosed lesion below the knee.The lesion was not predilated.The pt2 passed the lesion and a percutaneous transluminal angioplasty balloon catheter advanced over the pt2 guidewire.The tip of the pt2 guidewire was observed broken.The pt2 was removed and the procedure stopped due to this event.No patient complications were reported.The patient condition was stable following the procedure.
Event or Problem Description
It was reported that tip break and cancelled procedure occurred.A 300cm pt2 guidewire was selected for use in a non tortuous 85% stenosed lesion below the knee.The lesion was not predilated.The pt2 passed the lesion and a percutaneous transluminal angioplasty balloon catheter advanced over the pt2 guidewire.The tip of the pt2 guidewire was observed broken.The pt2 was removed and the procedure stopped due to this event.No patient complications were reported.The patient condition was stable following the procedure.It was further reported that the detached tip was snared and completely removed from the patient.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.H6 update: added additional device required f2301.

• Brand Name: PT
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15951621
• Report Number: 2124215-2022-51830
• Device Sequence Number: 7334423
• Product Code: DQX
• UDI-Device Identifier: 08714729471257
• UDI-Public: 08714729471240
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 01/05/2024
• Device Model Number: 2783
• Device Catalogue Number: 2783
• Device Lot Number: 0028633444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• 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 Age: 65 YR
• Patient Sex: Male