MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM STRAIGHT TIP STEERABLE GU; WIRE, GUIDE, CATHETER

Model Number	M001508100
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During emergent procedure to embolize an acute bleed, end of fathom wire broke off and remains in the body.Patient was dnr(do not resuscitate), it was felt to be more dangerous to attempt to retrieve the foreign object versus leaving it in the patient.

• Brand Name: FATHOM STRAIGHT TIP STEERABLE GU
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17059097
• Report Number: MW5118134
• Device Sequence Number: 6130318
• Product Code: DQX
• UDI-Device Identifier: 08714729801023
• UDI-Public: 08714729801023
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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: 03/06/2026
• Device Model Number: M001508100
• Device Lot Number: 31186223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Race: White