MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH

Model Number	80618
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the direxion microcatheter became stuck in the vessel.A direxion microcatheter was selected for the prostatic artery embolization procedure.During the procedure, the microcatheter became stuck in the vessel and was difficult to withdraw.The physician cut off the hub of the microcatheter to remove the 5 french guide catheter.A non-bsc microsnare kit was used to remove the direxion microcatheter from the vessel.A second direxion microcatheter was used and the same issue occurred.The procedure was ended.There were no patient complications reported.However, the patient was hospitalized beyond the standard of care.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13997176
• Report Number: 2134265-2022-03874
• Device Sequence Number: 4339700
• Product Code: KRA
• UDI-Device Identifier: 08714729839361
• UDI-Public: 08714729839361
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142259
• 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
• Report Date (Section B): 04/04/2022

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: 11/30/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0028469756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White