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

Model Number	39615
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The guidewire was returned, and it was observed that the coil wire was unraveled and stretched at distal end section, and the core wire was detached.Under microscope it was observed that the coil wire was unraveled and stretched at distal end, and the core wire was detached at transition point.The detached section is at 3.5 cm at transition point from the distal tip.Inspection of the remainder of the device revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 14dec2022.It was reported that the spring tip unraveled.An amplatz-pi guidewire was selected for use to perform a transjugular intrahepatic portosystemic stent shunt (tipss).During the procedure, the spring tip unraveled.A new amplatz-pi guidewire was selected and used to complete the procedure.There were no patient complications.However, analysis revealed that the core wire had detached.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16030149
• Report Number: 2124215-2022-53487
• Device Sequence Number: 17948005
• Product Code: DQX
• UDI-Device Identifier: 08714729115854
• UDI-Public: 08714729115854
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/21/2022

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: 05/04/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0029345975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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