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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used during an ureteroscopy procedure on (b)(6) 2022.During the procedure, when the guidewire was placed inside patient, it unraveled, and the core wire broke.The procedure was completed with a new amplatz super stiff.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used during an ureteroscopy procedure on (b)(6) 2022.During the procedure, when the guidewire was placed inside patient, it unraveled, and the core wire broke.The procedure was completed with a new amplatz super stiff.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
H6 (device code): problem code a0401 captures the reportable event of core wire broken.H10: the returned amplatz super stiff was analyzed, and a visual evaluation noted that the coil wire was unraveled at distal section and the corewire was detached at 2.7 cm from distal tip section to the transition point.Therefore, the reported complaint was confirmed.Boston scientific has determined the most probable cause of this complaint is manufacturing deficiency.Since the problem found was traced to the design specification and an investigation to address this problem is in progress.

• 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: 16218764
• Report Number: 3005099803-2023-00114
• Device Sequence Number: 14933774
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/06/2023

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: 09/25/2025
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0030224843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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