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

Model Number	39575
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire became entrapped in the biliary stent and fractured.An amplatz s/s st/035/145 (bx/1) super stiff guidewire was selected for use with a biliary stent.The guidewire became entrapped in the biliary stent and had fractured into two parts, the structure and the assembly.The fracture was noticed when the guidewire was being removed from the patient.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Event or Problem Description
It was reported that the guidewire became entrapped in the biliary stent and fractured.An amplatz s/s st/035/145 (bx/1) super stiff guidewire was selected for use with a biliary stent.The guidewire became entrapped in the biliary stent and had fractured into two parts, the structure and the assembly.The fracture was noticed when the guidewire was being removed from the patient.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
Device evaluation by manufacturer: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was inspected according to procedure.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 2.5cm at transition point from the distal tip (the specification of the length from the transition point to the distal tip is: 3.0cm plus or minus 0.5cm.) the device was measured according to the drawings.All measurements were within specification.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• 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: 15583107
• Report Number: 2124215-2022-40486
• Device Sequence Number: 17766931
• Product Code: DQX
• UDI-Device Identifier: 08714729295723
• UDI-Public: 08714729295723
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 05/23/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029462719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown