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

Model Number	39575
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device coating was damaged.This 035/260/1 (bx/5) amplatz super stiff guidewire was selected for use during a carotid intervention procedure.During the procedure, while inserting the guidewire into the sheath, it was noticed that the coating on the proximal end of the guidewire was damaged.The procedure was completed with another of the same device.There were no patient complications.
Event or Problem Description
It was reported that the device coating was damaged.This 035/260/1 (bx/5) amplatz super stiff guidewire was selected for use during a carotid intervention procedure.During the procedure, while inserting the guidewire into the sheath, it was noticed that the coating on the proximal end of the guidewire was damaged.The procedure was completed with another of the same device.There were no patient complications.It was further reported that the coating on the wire had shifted and became bumpy at the middle and end of the body of the wire.The wire was in the patients body with a diagnostic catheter and became stuck.The catheter and wire were removed from the body.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, visual inspection of this guidewire revealed a jump coil/deformation in the guidewire and the coating was peeling.Based on the investigation, the clinical observations were confirmed.
Event or Problem Description
It was reported that the device coating was damaged.This 035/260/1 (bx/5) amplatz super stiff guidewire was selected for use during a carotid intervention procedure.During the procedure, while inserting the guidewire into the sheath, it was noticed that the coating on the proximal end of the guidewire was damaged.The procedure was completed with another of the same device.There were no patient complications.It was further reported that the coating on the wire had shifted and became bumpy at the middle and end of the body of the wire.The wire was in the patients body with a diagnostic catheter and became stuck.The catheter and wire were removed from the body.

• 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: 20749807
• Report Number: 2124215-2024-73494
• Device Sequence Number: 12852554
• Product Code: DQX
• UDI-Device Identifier: 08714729115953
• UDI-Public: 08714729115953
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/13/2025

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 Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0034029418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 12/27/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/10/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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