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

Model Number	2781
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred and remains in the patient.A 300cm moderate support straight pt guidewire was advanced for use.However, during the procedure, the tip detached and was remains in the patient.The tip was trapped in an occlusion, so reported as minimal risk.There were no patient complications reported.
Event or Problem Description
It was reported that tip detachment occurred and remains in the patient.A 300cm moderate support straight pt guidewire was advanced for use.However, during the procedure, the tip detached and was remains in the patient.The tip was trapped in an occlusion, so reported as minimal risk.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch batch 24654033.The unit returned has the tip damaged, as part of overall visual revision.The device returned with the distal tip kink and stretched.The distal tip has a missing portion of approximately 0.8 inch as it remains in the patient.The device was measured in three sections along it in order to confirm that is within specification.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• 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: 12469415
• Report Number: 2134265-2021-11591
• Device Sequence Number: 3939837
• Product Code: DQX
• UDI-Device Identifier: 08714729471233
• UDI-Public: 08714729471233
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/28/2021

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: 10/23/2021
• Device Model Number: 2781
• Device Catalogue Number: 2781
• Device Lot Number: 0024654033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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 Sex: Unknown