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

Model Number	39615
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the balloon froze on the guidewire, and a guidewire coating issue occurred.This 035/260/3mm amplatz super stiff guide wire was selected for use during a percutaneous venous stenting procedure for iliac vein compression.During the procedure, after the location of the lesion was determined by sheath angiography, this 035/260/3mm amplatz super stiff guide wire was used with a 10x 80 mustang balloon.Upon advancing the balloon, a large resistance was observed, and the balloon became stuck.At that time, it was noted that there was a small substance falling off the guidewire, which was suspected to be the coating.The guidewire could no longer be used; therefore, the procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient was stable post procedure.
Event or Problem Description
It was reported that the balloon froze on the guidewire, and a guidewire coating issue occurred.This 035/260/3mm amplatz super stiff guide wire was selected for use during a percutaneous venous stenting procedure for iliac vein compression.During the procedure, after the location of the lesion was determined by sheath angiography, this 035/260/3mm amplatz super stiff guide wire was used with a 10x 80 mustang balloon.Upon advancing the balloon, a large resistance was observed, and the balloon became stuck.At that time, it was noted that there was a small substance falling off the guidewire, which was suspected to be the coating.The guidewire could no longer be used; therefore, the procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for analysis.Visual and microscope inspections were performed.It was observed that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point.Also, the guidewire was kinked and stretched at distal section.No other issues were identified with the device.

• 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: 21646219
• Report Number: 2124215-2025-16933
• Device Sequence Number: 15346976
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: (01)08714729115861(17)270620(10)34282730
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0034282730
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10X 80 MUSTANG BALLOON; 10X 80 MUSTANG BALLOON
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 77 KG