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

Model Number	39615
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that core wire detachment occurred.The 50% stenosed target lesion was located in the non- tortuous and non-calcified femoral artery.A 035/145/3mm amplatz super stiff guidewire was advanced, however, it was found under fluoroscopy that the tip was seriously kinked.The physician pulled the wire back out of the sheath and inspected it.The outer support coil was loosened, and the inner core wire of amplatz was broken.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire was returned, and it was observed that the coil wire was unraveled and kinked, additionally the core wire was detached at 3.1 cm from the distal tip to the transition point.No more damages were observed.Under microscope it was observed that the coil wire was unraveled and, and the core wire was detached at the transition point.
Event or Problem Description
It was reported that core wire detachment occurred.The 50% stenosed target lesion was located in the non- tortuous and non-calcified femoral artery.A 035/145/3mm amplatz super stiff guidewire was advanced, however, it was found under fluoroscopy that the tip was seriously kinked.The physician pulled the wire back out of the sheath and inspected it.The outer support coil was loosened, and the inner core wire of amplatz was broken.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16507247
• Report Number: 2124215-2023-08619
• Device Sequence Number: 3353921
• Product Code: DQX
• UDI-Device Identifier: 08714729115847
• UDI-Public: 08714729115847
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 02/21/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0028919087
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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: 61 YR
• Patient Sex: Female