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

Model Number	39575
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that coating issues occurred.An amplatz super stiff was selected for use during this thrombus aspiration in deep vein thrombosis of lower extremities procedure.Prior to the procedure, when the physician opened the outer package and pulled out the device, it was noted that there were burrs on the guidewire and had a distinct tactile sensation.The wire could not enter the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that coating issues occurred.An amplatz super stiff was selected for use during this thrombus aspiration in deep vein thrombosis of lower extremities procedure.Prior to the procedure, when the physician opened the outer package and pulled out the device, it was noted that there were burrs on the guidewire and had a distinct tactile sensation.The wire could not enter the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the guidewire had obvious protrusions and was uneven.
Event or Problem Description
It was reported that coating issues occurred.An amplatz super stiff was selected for use during this thrombus aspiration in deep vein thrombosis of lower extremities procedure.Prior to the procedure, when the physician opened the outer package and pulled out the device, it was noted that there were burrs on the guidewire and had a distinct tactile sensation.The wire could not enter the catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the guidewire had obvious protrusions and was uneven.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: the amplatz super stif was returned for analysis.The coating was peeled at the distal and proximal sections of the guidewire.The device was inspected under magnification, and it was possible to see that the coating was peeled at the distal and proximal sections of the guidewire.

• 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: 23084258
• Report Number: 2124215-2025-65002
• Device Sequence Number: 19994865
• Product Code: DQX
• UDI-Device Identifier: 08714729115953
• UDI-Public: (01)08714729115953(17)280330(10)36196567
• 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,Followup
• Report Date (Section B): 12/08/2025

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: 0036196567
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 11/19/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/21/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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: 59 YR
• Patient Sex: Female