MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401081
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used in the kidney during a ureteroscopy procedure on (b)(6) 2023.During the procedure, when the guidewire was placed inside the patient, it unraveled, and the core wire broke.Reportedly, the broken tip was retrieved.The physician used a second amplatz guidewire, and the same problem occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.Block h6 (impact code): imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block h6 (device code): imdrf device code a0401 captures the reportable event of core wire broken.
Additional Manufacturer Narrative
Block a2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.Block h6 (impact code): imdrf impact code f23 captures the reportable event of unexpected medical intervention.Block h6 (device code): imdrf device code a0401 captures the reportable event of core wire broken.Block h10: the returned amplatz super stiff was analyzed, a visual and microscopic evaluation noted that the coil wire unraveled due to the core wire found detached approximately 2.8 cm from the distal tip to the transition point.Additionally, the core wire was kinked in the distal section.Media inspection shows that the core wire was detached and separated at the transition point.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event of core wire break and device unraveled material was confirmed.Based on the condition of the returned device, it is probable that the functionality of the device could be affected by an excess of force, manipulation, and the technique used could have contributed to the reported event.Therefore, the most probable cause of this complaint is manufacturing deficiency.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used in the kidney during a ureteroscopy procedure on (b)(6) 2023.During the procedure, when the guidewire was placed inside the patient, it unraveled, and the core wire broke.Reportedly, the broken tip was retrieved.The physician used a second amplatz guidewire, and the same problem occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17282900
• Report Number: 3005099803-2023-03618
• Device Sequence Number: 11658789
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2024
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0027969872
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male