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

Model Number	39615
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	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6), reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that guidewire coating issue occurred.The patient underwent right atrial appendage occlusion.A 035/260/3mm amplatz super stiff was selected for use.During the procedure, it was noted that the thickness of the guidewire was not even, and the guidewire could not be used.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 facility name: (b)(6).E1: initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that guidewire coating issue occurred.The patient underwent right atrial appendage occlusion.A 035/260/3mm amplatz super stiff was selected for use.During the procedure, it was noted that the thickness of the guidewire was not even, and the guidewire could not be used.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 there is a visible physical appearance of the guidewire coating that was uneven.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.Device eval by mfr: the amplatz super stiff was returned for analysis and investigation was completed.Visual and microscopic inspection revealed that it was observed that a bent at distal tip occurred and the coating was peeled.
Event or Problem Description
It was reported that guidewire coating issue occurred.The patient underwent right atrial appendage occlusion.A 035/260/3mm amplatz super stiff was selected for use.During the procedure, it was noted that the thickness of the guidewire was not even, and the guidewire could not be used.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 there is a visible physical appearance of the guidewire coating that was uneven.
Event or Problem Description
It was reported that guidewire coating issue occurred.The patient underwent right atrial appendage occlusion.A 035/260/3mm amplatz super stiff was selected for use.During the procedure, it was noted that the thickness of the guidewire was not even, and the guidewire could not be used.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 there is a visible physical appearance of the guidewire coating that was uneven.
Additional Manufacturer Narrative
E1:(b)(6).A1: patient identifier: updated.Device eval by mfr: the amplatz super stiff was returned for analysis and investigation was completed.Visual and microscopic inspection revealed that it was observed that a bent at distal tip occurred and the 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: 22894620
• Report Number: 2124215-2025-59153
• Device Sequence Number: 12241400
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: (01)08714729115861(17)271219(10)35527857
• 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,Followup
• Report Date (Section B): 02/19/2026

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: 0035527857
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/24/2025; 10/22/2025; 01/25/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/18/2025; 11/18/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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 Age: 67 YR
• Patient Sex: Male