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

Model Number	2777
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal tip of the guidewire detached.A 185cm pt2 moderate support guidewire was selected for procedure.During withdrawal, the distal tip of the guidewire detached.Approximately 1.5 cm distal part of the guidewire remained in the patients coronary artery.The wire has not been in a jail position and kinking has been seen on the coronary artery.The procedure completed with this procedure.There were no further patient complications, and the patient was stable.
Event or Problem Description
It was reported that the distal tip of the guidewire detached.A 185cm pt2 moderate support guidewire was selected for procedure.During withdrawal, the distal tip of the guidewire detached.Approximately 1.5 cm distal part of the guidewire remained in the patient's coronary artery.The wire has not been in a jail position and kinking has been seen on the coronary artery.The procedure completed with this procedure.There were no further patient complications, and the patient was stable.It was further reported that the 99% stenosed target lesion in the none tortuous and none calcified proximal intermediate branch.The target lesion itself was not tortuous, but the distal part of the vessel was tortuous.The guidewire was in the distal part of the vessel.The guidewire broken due to the distal part of the vessel was kinking force.The physician did not make any attempts to retrieve the detached guidewire fragment because it was impossible to snare it without the chance of serious complication.The target lesion was treated successfully with another device.The patient is doing well.
Additional Manufacturer Narrative
Device evaluated by manufacturer: a visual examination of the returned device revealed that the guidewire was found kinked.Microscopic inspection of the guidewire showed the guidewire detached at the distal tip.Dimensional inspection was performed and the distal, medium and proximal of the guidewire were within specifications.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the distal tip of the guidewire detached.A 185cm pt2 moderate support guidewire was selected for procedure.During withdrawal, the distal tip of the guidewire detached.Approximately 1.5 cm distal part of the guidewire remained in the patient's coronary artery.The wire has not been in a jail position and kinking has been seen on the coronary artery.The procedure completed with this procedure.There were no further patient complications, and the patient was stable.It was further reported that the 99% stenosed target lesion in the none tortuous and none calcified proximal intermediate branch.The target lesion itself was not tortuous, but the distal part of the vessel was tortuous.The guidewire was in the distal part of the vessel.The guidewire broken due to the distal part of the vessel was kinking force.The physician did not make any attempts to retrieve the detached guidewire fragment because it was impossible to snare it without the chance of serious complication.The target lesion was treated successfully with another device.The patient is doing well.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13549508
• Report Number: 2134265-2022-01786
• Device Sequence Number: 5023809
• Product Code: DQX
• UDI-Device Identifier: 08714729471219
• UDI-Public: 08714729471219
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2022

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: 10/23/2023
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0028258568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/03/2022; 03/30/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/21/2022; 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2021
• 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: 76 YR
• Patient Sex: Female