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

Model Number	M0066401081
Medical Device Problem Codes	Unraveled Material (1664); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0501 captures the reportable event of coil wire detached.Block h6 (patient codes): imdrf patient code e2114 captures the reportable event of perforation.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff was used during a left arm arteriovenous fistula (avf) procedure performed on (b)(6) 2023.During procedure, the tip of the amplatz wire unraveled and detached.In addition, the avf vessel was also perforated.A snare was used to retrieve the detached tip of wire and stent was placed to stop bleeding from wire perforation.Per physician's opinion, the amplatz wire cause or contribute to the patient's perforation.It was reported that the patient was fully recovered.Note: the instructions for use (ifu) indicate that the amplatz super stiff guidewire is intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures and not intended for coronary artery, vascular or neurological use; however, the amplatz wire was used to facilitate placement in the left arm arteriovenous fistula for this case.

• 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: 16878166
• Report Number: 3005099803-2023-02402
• Device Sequence Number: 12191989
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2025
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0029911445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown