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

Model Number	39575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire coating peeled.A 0.035in x 180cm straight tip amplatz super stiff guidewire was selected for use in a percutaneous transhepatic cholangiogram procedure.However, during the initial manipulation of the guidewire under fluoroscopy, the distal end of the guidewire had become split.The coating had peeled.The device was carefully removed in one piece.It was confirmed no fragments were left in the patient.The procedure was completed with another amplatz super stiff guidewire.No patient complications were reported.
Event or Problem Description
It was reported that the guidewire coating peeled.A 0.035in x 180cm straight tip amplatz super stiff guidewire was selected for use in a percutaneous transhepatic cholangiogram procedure.However, during the initial manipulation of the guidewire under fluoroscopy, the distal end of the guidewire had become split.The coating had peeled.The device was carefully removed in one piece.It was confirmed no fragments were left in the patient.The procedure was completed with another amplatz super stiff guidewire.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the guidewire was returned for analysis, and it was observed that the core wire was found separated from the bald weld.Additionally, the guidewire was stretched and bent at the distal section.The reported coating issue could not be confirmed.

• 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: 20546884
• Report Number: 2124215-2024-67058
• Device Sequence Number: 7225414
• Product Code: DQX
• UDI-Device Identifier: 08714729115823
• UDI-Public: 08714729115823
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K843014
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 0033003509
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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 Sex: Unknown