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

Model Number	39615
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in jugular vein.During a transjugular liver biopsy, a 035/180/3mm amplatz super stiff guidewire was advanced for use.However, during advancing, resistance was felt and when the guidewire was pulled out of the sheath, the guidewire had fractured/shredded.The device was simply removed, and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the complaint device was not returned by the customer, nevertheless the customer did provide four photos related to the complaint and, it is possible to see that the guidewire was unraveled and kinked at the distal tip.No more damages were observed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in jugular vein.During transjugular liver biopsy, a 035/180/3mm amplatz super stiff guidewire was advanced for use.However, during advancing, resistance was felt and when the guidewire was pulled out of the sheath, the guidewire had fractured/shredded.The device was simply removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 17252519
• Report Number: 2124215-2023-34371
• Device Sequence Number: 6840324
• Product Code: DQX
• UDI-Device Identifier: 08714729295648
• UDI-Public: 08714729295648
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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 Expiration Date: 10/19/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0030388351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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