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

Model Number	M0066401041
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned guidewire revealed that the core wire was broken, kinked and unraveled.Additionally, the coil wire was found stretched.It was found during the investigation of the returned guidewire that the core wire was broken.It is most likely the issue could be caused during manipulation of the device or due to the interaction with other devices.Moreover, the outer diameter dimensions were found within specification.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff guidewire was used in the right ureter during a cystourethroscopy, ureteroscopy, retrograde pyelogram, insertion of right double j ureteral stent and dilation of meatal stenosis procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the amplatz guidewire was difficult to advance and appeared unraveled.The procedure was completed with a different guidewire.There were no reported patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results.

• 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: 9098930
• Report Number: 3005099803-2019-04678
• Device Sequence Number: 16800197
• Product Code: EZB
• UDI-Device Identifier: 08714729191148
• UDI-Public: 08714729191148
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/20/2019

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: 11/26/2021
• Device Model Number: M0066401041
• Device Catalogue Number: 640-104
• Device Lot Number: 0022994674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1