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

Model Number	M0066401060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was the over the age of 18.(b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff urology guidewire was used in the superficial femoral artery (sfa) during a lower extremity angiogram procedure performed on (b)(6) 2018.Per the device's directions for use (dfu) it states that the amplatz urology guidewire is not intended for coronary or vascular use.According to the complainant, during the procedure, the amplatz super stiff urology guidewire and the catheter (manufacturer unknown) got stuck.The amplatz super stiff urology guidewire became shredded, and the tip of the catheter broke off in the patient.The detached portion of the catheter tip was retrieved from the patient.Reportedly, the catheter was not a bsc product.The patient's iliac artery was apparently torn, and the cause is unknown.The patient bled out and died.It is unknown if the devices were related to the cause of death.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 7933555
• Report Number: 3005099803-2018-60685
• Device Sequence Number: 941321
• Product Code: EZB
• UDI-Device Identifier: 08714729752684
• UDI-Public: 08714729752684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 10/04/2018

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: 02/04/2021
• Device Model Number: M0066401060
• Device Catalogue Number: 66495
• Device Lot Number: 0021703689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death