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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device detachment occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 185cm pt guide catheter was advanced for treatment.After the wire was placed in the distal lad, the lesion was ballooned and then stented.The stent balloon was removed.However, when removing the wire from the vessel, the doctor noticed that the radiopaque end of the wire remained in the vessel and required snaring for removal.The procedure was completed and there were no patient complications.

• 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: 15058949
• Report Number: 2124215-2022-26309
• Device Sequence Number: 17336581
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 08714729471202
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/19/2022

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: 10/13/2023
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0028196252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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: Required Intervention
• Patient Sex: Unknown