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

Model Number	2781
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.Vascular access was obtained via pedal access through the anterior tibial artery (ata).The target lesion was located in the severely tortuous and moderately calcified peroneal artery (pa).A 300cm moderate support pt2 guidewire was advanced for treatment.The wire was looped up over tibioperoneal (tp) trunk into pa.The ata into the tp trunk was ballooned, however, during insertion of the balloon, the mid of the wire broke at the level of the tp trunk.The broken wire was completely removed using a snare through the ata.The procedure was then stopped as removal of the wire piece took too much time and radiation.No patient complications were reported and the patient was fully recovered.
Additional Manufacturer Narrative
B5 describe event or problem updated.H6 device codes: failure to advance (a150204) added.
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.Vascular access was obtained via pedal access through the anterior tibial artery (ata).The target lesion was located in the severely tortuous and moderately calcified peroneal artery (pa).A 300cm moderate support pt2 guidewire was advanced for treatment.The wire was looped up over tibioperoneal (tp) trunk into pa.The ata into the tp trunk was ballooned, however, during insertion of the balloon, the mid of the wire broke at the level of the tp trunk.The broken wire was completely removed using a snare through the ata.The procedure was then stopped as removal of the wire piece took too much time and radiation.No patient complications were reported, and the patient was fully recovered.It was further reported that this is via facility maude reference # mw5117595.
Additional Manufacturer Narrative
B5 describe event or problem updated.H6 device codes: failure to advance (a150204) added.Device evaluated by mfr.: the pt2 device was returned and the overall visual investigation did not identify any issues or failure.Microscopic inspection noted no issues on the distal side and proximal side the device.The guidewire was measured using a calibrated ruler and met specification.A media inspection was performed on the provided angiography pictures, however no evidence that could relate to the reported allegation was encountered.During product analysis no issues were found that could be related to the reported issue.Therefore, the reported complaint is not confirmed.
Event or Problem Description
It was reported that guidewire fracture occurred requiring additional intervention.Vascular access was obtained via pedal access through the anterior tibial artery (ata).The target lesion was located in the severely tortuous and moderately calcified peroneal artery (pa).A 300cm moderate support pt2 guidewire was advanced for treatment.The wire was looped up over tibioperoneal (tp) trunk into pa.The ata into the tp trunk was ballooned, however, during insertion of the balloon, the mid of the wire broke at the level of the tp trunk.The broken wire was completely removed using a snare through the ata.The procedure was then stopped as removal of the wire piece took too much time and radiation.No patient complications were reported, and the patient was fully recovered.It was further reported that this is via facility maude reference # mw5117595.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17021262
• Report Number: 2124215-2023-26314
• Device Sequence Number: 7549504
• Product Code: DQX
• UDI-Device Identifier: 08714729471257
• UDI-Public: 08714729471257
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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: 11/03/2024
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0030481049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 08/03/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/13/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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 Sex: Unknown