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

Model Number	39575
Medical Device Problem Codes	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	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.
Event or Problem Description
It was reported that the wire coating was peeling off.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified iliac vein.An amplatz super stiff guidewire was selected for venous thrombectomy procedure.When the wire was inserted in the wire lumen of the 13f non-boston scientific sheath, it felt very tight, and the coating near the proximal end appeared to be peeling off.The system was removed, and found the entire length of the wire coating was peeled off.The procedure was completed with a new amplatz wire.There was no patient complications noted as a result of this event.
Event or Problem Description
It was reported that the wire coating was peeling off.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified iliac vein.An amplatz super stiff guidewire was selected for venous thrombectomy procedure.When the wire was inserted in the wire lumen of the 13f non-boston scientific sheath, it felt very tight, and the coating near the proximal end appeared to be peeling off.The system was removed, and found the entire length of the wire coating was peeled off.The procedure was completed with a new amplatz wire.There was no patient complications noted as a result of this event.
Additional Manufacturer Narrative
A2 age at time of event: 18 years or older.Device evaluation by manufacturer: the device was returned for analysis.Visual inspection observed that it was kinked at distal tip.Microscopic inspection of the ptfe coating was peeled.

• 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: 22150669
• Report Number: 2124215-2025-34382
• Device Sequence Number: 8394019
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: (01)08714729295655(17)270824(10)34706713
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/06/2025

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: 0034706713
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• 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: INTRODUCER SHEATH: 13F CLOTTRIEVER; INTRODUCER SHEATH: 13F CLOTTRIEVER
• Patient Sex: Male