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

Model Number	2779
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire detachment occurred.The target lesion was located in the distal left circumflex artery or posterolateral branch.A 185cm straight pt2 guidewire was advanced to cross the lesion.However, during the procedure, the device was separated slightly longer than the middle of the radiopaque marker.The separated part was inside the patient body and the remaining wire was missing.The procedure was cancelled/rescheduled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was inspected and no failures were found.The surface of the device was carefully inspected and no abnormalities were observed, it was smooth and uniform.Also the distal and proximal tip were inspected and no failures were found.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.The device was within specification.
Event or Problem Description
It was reported that guide wire detachment occurred.The target lesion was located in the distal left circumflex artery or posterolateral branch.A 185cm straight pt2 guidewire was advanced to cross the lesion.However, during the procedure, the device was separated slightly longer than the middle of the radiopaque marker.The separated part was inside the patient body and the remaining wire was missing.The procedure was cancelled/rescheduled.No patient complications were reported.

• 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: 12787162
• Report Number: 2134265-2021-14042
• Device Sequence Number: 3874344
• Product Code: DQX
• UDI-Device Identifier: 08714729471103
• UDI-Public: 08714729471103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/08/2021

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: 05/11/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025504473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMAGING CATHETER: OPTICROSS; IMAGING CATHETER: OPTICROSS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown