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

Model Number	80618
Medical Device Problem Codes	Fracture (1260); 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.
Additional Manufacturer Narrative
B5: updated event description.Device eval by manufacturer: the direxion microcatheter was returned to boston scientific for analysis.The device was received in three pieces and was inspected for damage or irregularities.The hub was not returned.The first piece did not have an inner tube.The middle piece was 13.6cm long and had fractures at 2.9cm and 8.2cm from the proximal end.The last piece, which had the tip on it, had fractures 2.3cm and 2.6cm from the tip and a kink 2.2cm from the tip.A fracture was confirmed on the direxion microcatheter.
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.It was further reported that when performing multiple attempts to release the catheter from where it was stuck in the prostatic artery by gently turning, pushing, applying nitrogen, and pulling, the outer layer of the device fractured.

• 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: 13997154
• Report Number: 2134265-2022-03873
• Device Sequence Number: 5317144
• 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,Followup
• Report Date (Section B): 05/26/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White