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

Model Number	39575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.A 035/145 (bx/1) amplatz super stiff guidewire was used.However, during the procedure, the wire delaminated as the coating at the distal tip of the wire separated and peeled off from its coating.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag; overall visual revision identified the tip detached.The costumer provides one photos of the pouch, and it was observed that the pouch information matches with the complaint information.The guidewire was returned for the analysis, and it was observed that the coil wire was unraveled due the guidewire was found detached separated approximately 2.7cm from distal tip to the transition point.Additionally, the guidewire was kinked at the distal section.Under microscope it was observed that the core wire was detached separated at the transition point and the coil wire was unraveled and detached.
Event or Problem Description
It was reported that coating issue occurred.A 035/145 (bx/1) amplatz super stiff guidewire was used.However, during the procedure, the wire delaminated as the coating at the distal tip of the wire separated and peeled off from its coating.No patient complications were reported.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16714588
• Report Number: 2124215-2023-16334
• Device Sequence Number: 20648897
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 11/08/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0030513749
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: 52 YR
• Patient Sex: Male