MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39615
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: event date not provided and estimated based on the aware date.
Event or Problem Description
It was reported that the distal tip of the guidewire broke.An amplatz pi guidewire was selected for use in a radiology procedure.During the procedure, the distal tip broke.No patient complications were reported.
Event or Problem Description
It was reported that the distal tip of the guidewire broke.An amplatz pi guidewire was selected for use in a radiology procedure.During the procedure, the distal tip broke.No patient complications were reported.It was further reported that the target lesion was located in the hepatic vein.The distal tip broke during withdrawal of the device.It was completely removed through the catheter.The procedure was completed with another device, same model.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the guidewire was received, and analysis was completed.Media provided showed that the core wire was detached at distal tip section, and the coil wire was unraveled, no other damages were observed.Visual inspection revealed that the core wire was detached at 3.5 cm from distal tip to the transition point, and the coil wire was unraveled at distal section.Under microscope it was observed that the core wire was detached at the transition point, and the coil wire was unraveled at distal section.Inspection of the remainder of the device revealed no other damage or irregularities.
Event or Problem Description
It was reported that the distal tip of the guidewire broke.An amplatz pi guidewire was selected for use in a radiology procedure.During the procedure, the distal tip broke.No patient complications were reported.It was further reported that the target lesion was located in the hepatic vein.The distal tip broke during withdrawal of the device.It was completely removed through the catheter.The procedure was completed with another device, same model.

• Brand Name: AMPLATZ SUPER STIFF
• 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: 15953835
• Report Number: 2124215-2022-51819
• Device Sequence Number: 7302914
• Product Code: DQX
• UDI-Device Identifier: 08714729115854
• UDI-Public: 08714729115854
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K843012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2023

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: 05/04/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0029345975
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 12/23/2022; 01/24/2023
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/17/2023; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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 Sex: Unknown