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

Model Number	M0066401091
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.(b)(4).The returned amplatz super stiff was analyzed.The corewire broke, ptfe peeled off, and coil wire was stretched.Based on the condition of the returned device, engineers determined that the problem observed may be related with some other factors such as; handling of the device, the technique used by the physician and normal procedural difficulties encountered during the preparation that could have possibly affected the device performance and its integrity.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.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used in a procedure.The procedure date is unknown.During preparation, the ptfe coating peeled.The procedure was completed with a new amplatz super stiff.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 break.Please see block h10 for full investigation details.

• 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: 15508900
• Report Number: 3005099803-2022-05579
• Device Sequence Number: 17606316
• Product Code: EZB
• UDI-Device Identifier: 08714729191193
• UDI-Public: 08714729191193
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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: 06/22/2025
• Device Model Number: M0066401091
• Device Catalogue Number: 640-109
• Device Lot Number: 0029644775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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