MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84592
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the severely tortuous type ii endo leak.A direxion fathom-16 system was selected for use.During the procedure, after delivering three coils and upon twisting the hub of the microcatheter, it was noted that the hub broke outside the patient's body and was unable to deploy any more.The microcatheter was completely removed and the physician lost access and was unable to complete the procedure.The patient may still have endo leak and may have to be rebooked, and will require ct imaging to assess the endo leak.No patient complications were reported and the patient was stable post procedure.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the severely tortuous type ii endo leak.A direxion fathom-16 system was selected for use.During the procedure, after delivering three coils and upon twisting the hub of the microcatheter, it was noted that the hub broke outside the patient's body and was unable to deploy any more.The microcatheter was completely removed and the physician lost access and was unable to complete the procedure.The patient may still have endo leak and may have to be rebooked, and will require ct imaging to assess the endo leak.No patient complications were reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation located 3.4cm form the strain relief with the inner shaft stretched for 13.2cm with numerous kinks, inner shaft was twisted, and an outer shaft separation located 26.2cm from the strain relief.Inspection of the rest of the device found no other damage or defect.

• Brand Name: DIREXION FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10482784
• Report Number: 2134265-2020-12132
• Device Sequence Number: 3394973
• Product Code: KRA
• UDI-Device Identifier: 08714729839637
• UDI-Public: 08714729839637
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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: 05/22/2022
• Device Model Number: 84592
• Device Catalogue Number: 84592
• Device Lot Number: 0025532422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1