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

Model Number	M0066401081
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed the core wire broken approximately 142 cm from the proximal end.The other section of the core wire was attached to the distal end solder ball and this section measured approximately 2.7 cm from the distal end.Also, the guidewire was unraveled and kinked.The coil wire was found stretched and was not broken.No damages on the coating were observed and guidewire surface showed some small drag marks near the proximal end.The complaint is consistent with the reported event.The affected area of the coating was in contact with a harder surface, causing the damage on the coating.Therefore, a conclusion code of adverse event related to procedure because of the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a amplatz guidewire was used in the ureter during ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the guidewire was withdrawn, the physician noticed that the coating had come off approximately two inches in length.Reportedly, the detached coating was retrieved during the same procedure.The procedure was completed this 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 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: 9841251
• Report Number: 3005099803-2020-01063
• Device Sequence Number: 2886831
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/17/2020

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: 06/13/2022
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0023956426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1