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

Model Number	M0066401091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A portion of amplatz super stiff guidewire was returned.Visual analysis revealed that the guidewire was unraveled, coil wire was stretched and broken.In addition, the core wire was broken and kinked at distal section.The distal end section was not returned.With the available information, boston scientific concludes that the reported amplatz super stiff guidewire corewire and coilwire were broken.Based on the condition of the returned device, engineers determined that the failure modes were caused by the way in which the device was handled (excessively and/or forcefully) during procedure or during interaction with the other devices.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.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 in a procedure.Procedure date is unknown.During preparation, the guidewire distal tip detached.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: corewire and coilwire were 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: 11923521
• Report Number: 3005099803-2021-02617
• Device Sequence Number: 13664945
• Product Code: EZB
• UDI-Device Identifier: 08714729191193
• UDI-Public: 08714729191193
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 01/12/2024
• Device Model Number: M0066401091
• Device Catalogue Number: 640-109
• Device Lot Number: 0026623760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1