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	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that tip detachment occurred.The patient was supine and underwent anterograde puncture of the right femoral artery.Mesenteric artery stenosis was detected by angiography and mesenteric artery stent implantation was performed.An amplatz super stiff was selected for use.During preparation, when opened, it was noted that the tip of the guidewire was cracked.The procedure was completed another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the guidewire was returned.Visual and microscope inspections were performed.It was observed that the guidewire was kinked and stretched at distal section.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that tip detachment occurred.The patient was supine and underwent anterograde puncture of the right femoral artery.Mesenteric artery stenosis was detected by angiography and mesenteric artery stent implantation was performed.An amplatz super stiff was selected for use.During preparation, when opened, it was noted that the tip of the guidewire was cracked.The procedure was completed another of the same device.No complications were reported, and the patient was stable post procedure.

• 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: 21753573
• Report Number: 2124215-2025-17086
• Device Sequence Number: 8200512
• Product Code: DQX
• UDI-Device Identifier: 08714729115830
• UDI-Public: (01)08714729115830(17)270604(10)34169604
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K843016
• 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): 06/05/2025

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: 0034169604
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG