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

Model Number	80618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter was broken.The target lesion was located in the moderately tortuous and non calcified liver.A direxion catheter infusion was selected for use.During procedure, the physician was trying to navigate a very tight hairpin turn.After several tries of trying to push the direxion microcatheter around this turn, he removed the device from the patient.During removal, it was noticed that the microcatheter was broken halfway up.The device was removed from the patient by pulling the device intact.The procedure was completed with a non boston scientific product.There were no patient complications reported.
Event or Problem Description
It was reported that the microcatheter was broken.The target lesion was located in the moderately tortuous and non calcified liver.A direxion catheter infusion was selected for use.During procedure, the physician was trying to navigate a very tight hairpin turn.After several tries of trying to push the direxion microcatheter around this turn, he removed the device from the patient.During removal, it was noticed that the microcatheter was broken halfway up.The device was removed from the patient by pulling the device intact.The procedure was completed with a non boston scientific product.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned and inspected for any damage or irregularities.The direxion showed damage in the form two kinks, 10cm from the hub and 56.5cm from the hub, both with the inner lining still intact.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.Device analysis determined the condition of the returned device was consistent with the reported information of a fracture.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11852240
• Report Number: 2134265-2021-06236
• Device Sequence Number: 3724263
• Product Code: KRA
• UDI-Device Identifier: 08714729839415
• UDI-Public: 08714729839415
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 09/22/2022
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0026055789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1