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

Model Number	39575
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: (media) the device was not returned by the costumer, nevertheless a picture was attached at complaint record; and it was observed that the coil wire was unraveled, and the core wire was detached.
Event or Problem Description
Reportable based on device analysis completed on 31jan2023.It was reported that unraveled guidewire occurred.A 35/145 amplatz super stiff guidewire was selected for use.However, upon opening the package, it was noticed that the wire was already frayed off.The procedure was completed with a different device.There were no patient complications reported.However, media analysis revealed a core wire detached/separated.
Additional Manufacturer Narrative
The guidewire was returned.A picture was attached to the complaint record; and it was observed that the coil wire was unraveled, and the core wire was detached.Visual and microscopic inspection revealed that the coil wire was unraveled, and the core wire was detached at 2.6 cm from the distal tip to the transition point.No more damages were observed.
Event or Problem Description
Reportable based on device analysis completed on 31jan2023.It was reported that unraveled guidewire occurred.A 35/145 amplatz super stiff guidewire was selected for use.However, upon opening the package, it was noticed that the wire was already frayed off.The procedure was completed with a different device.There were no patient complications reported.However, media analysis revealed a core wire detached/separated.

• 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: 16307150
• Report Number: 2124215-2023-04748
• Device Sequence Number: 17904652
• Product Code: DQX
• UDI-Device Identifier: 08714729295723
• UDI-Public: 08714729295723
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 08/08/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029919948
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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: 56 YR
• Patient Sex: Male