MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -14; WIRE, GUIDE, CATHETER

Model Number	81725
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three separate guidewire tips had fractured during use.A 300cmx10cm fathom-14 guidewire was selected for use.During the procedure, the guidewire tip fractured and about 10cm had torn off and remained in the vessel.The physician was able to remove the tip with a snare kit.The physician again attempted with two additional fathom-14 guidewires (300x10cm, 200x10cm), however both tips fractured/stretched leaving the tip nearly detached.The procedure was completed with another device without sequela.
Event or Problem Description
It was reported that three separate guidewire tips had fractured during use.A 300cmx10cm fathom-14 guidewire was selected for use.The patient was known to have gastrointestinal bleeding, as part of a tumor infiltration of the duodenum by the known pancreatic carcinoma and was intubated, ventilated and required intensive care.During the procedure, the guidewire tip fractured and about 10cm had torn off and remained in the vessel.The physician was able to remove the tip with a snare kit.The physician again attempted with two additional fathom-14 guidewires (300x10cm, 200x10cm), however both tips fractured/stretched leaving the tip nearly detached.The procedure was completed with another device without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a fathom-14 guidewire with its original pouch.Visual observation revealed the distal tip was separated at 8.1cm from the rest of the guidewire, and the core wire was also detached at 8.2cm.Analysis was able to confirm the report from the field of distal tip damage.

• Brand Name: FATHOM -14
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15395254
• Report Number: 2124215-2022-35149
• Device Sequence Number: 5007249
• Product Code: DQX
• UDI-Device Identifier: 08714729801054
• UDI-Public: 08714729801054
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 05/02/2025
• Device Model Number: 81725
• Device Catalogue Number: 81725
• Device Lot Number: 0029330280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: Required Intervention
• Patient Sex: Unknown