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	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment occurred.A 185cm j-tip pt guidewire was advanced to the target lesion.However, during procedure, the tip of the guide wire broke.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscopic inspection revealed the distal tip was detached from the body of the guidewire and not returned.A kink was also noted 30 cm from the proximal end.
Event or Problem Description
It was reported that device detachment occurred.A 185cm j-tip pt guidewire was advanced to the target lesion.However, during manipulation of the guidewire inside the vessel, the tip of the guide wire broke.No patient complications were reported and the patient condition post procedure was stable.The device was returned for analysis.Visual and microscopic inspection revealed the distal tip was detached from the body of the guidewire and not returned.A kink was also noted 30 cm from the proximal end.

• 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: 15619298
• Report Number: 2124215-2022-41523
• Device Sequence Number: 5961199
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 08714729471202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2024
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0029050847
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Male