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 Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned amplatz super stiff was analyzed, and a visual evaluation noted that the distal end unraveled and detached from the core wire.Additionally, the core wire is kinked.The device was observed under magnification and the distal end unraveled and detached from the core wire and the core wire is kinked.The device was measured in three sections (distal, medium, proximal) and it was found within specification.The distal measurements were not performed due to the condition of the device.No other problems with the device were noted.The product analysis revealed that the distal end of the guidewire unraveled and detached from the core wire.Additionally, the core wire is kinked.Based on the condition of the device, the problem found could have been caused by the way in which the device was handled (excessively and/or forcefully) during procedure.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff guidewire was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6)2020.According to the complainant, during the procedure, the amplatz super stiff guidewire was used to access into the kidney.However, when the physician retracted the amplatz super stiff guidewire, it unraveled.The procedure was completed with a new amplatz super stiff guidewire.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: core wire was broken.

• 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
• MDR Report Key: 11124633
• Report Number: 3005099803-2020-06509
• Device Sequence Number: 17135418
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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: 06/04/2023
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0025563476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1