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

Model Number	80618
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was fractured.A direxion catheter-infusion was selected for use.During the procedure, it was noted that resistance was felt and the device snapped.The microcatheter was taken out and a fracture was observed in the middle of the device.The procedure was completed with alternative method.There were no patient complications reported.
Event or Problem Description
It was reported that the microcatheter was fractured.A direxion catheter-infusion was selected for use.During the procedure, it was noted that resistance was felt and the device snapped.The microcatheter was taken out and a fracture was observed in the middle of the device.The procedure was completed with alternative method.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis and was inspected for any damage or irregularities.Device has signs of use and one fracture visible 3.8 cm from the hub.The shaft was not completely separated, the inner liner was still intact.Contrast was visible in the luer and on the catheter.The complaint of friction could not be addressed because the fracture precluded using another guide catheter for testing.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Device analysis determined the condition of the returned device was not consistent with the reported information of a break.A fracture was found.

• 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 CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13943748
• Report Number: 2134265-2022-03333
• Device Sequence Number: 11881304
• Product Code: KRA
• UDI-Device Identifier: 08714729839316
• UDI-Public: 08714729839316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 01/11/2024
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0028659037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Sex: Unknown