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 Codes	Vasoconstriction (2126); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that removal difficulty occurred.A direxion was selected for microcatheterization of an endoleak of the abdominal aorta via the arc of riolan.After embolization, major resistance occurred withdrawing the device causing peeling of the external frame of the microcatheter.An integrated portion of the microcatheter was found to aide in removal without leaving a fragment in the sma or the arc of riolan.A spasm was noticed at the beginning of the arc of riolan, with no prior functional repercussions.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that removal difficulty occurred.A direxion was selected for microcatheterization of an endoleak of the abdominal aorta via the arc of riolan.After embolization, major resistance occurred withdrawing the device causing peeling of the external frame of the microcatheter.An integrated portion of the microcatheter was found to aide in removal without leaving a fragment in the sma or the arc of riolan.A spasm was noticed at the beginning of the arc of riolan, with no prior functional repercussions.
Additional Manufacturer Narrative
Initial reporter phone: (b)(4).H6 patient codes, evaluation conclusion codes - updated.Device evaluated by mfr: the direxion was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.A fracture 40.9 cm from the hub was noted, but not a break.Kinks were measured at 51.8 cm and 52.9 cm from the hub.The report of peeling of the nitinol shaft was not confirmed.The device could not be inserted into a guide catheter due to the fracture so the report of friction could not be determined.
Event or Problem Description
It was reported that removal difficulty occurred.A direxion was selected for microcatheterization of an endoleak of the abdominal aorta via the arc of riolan.After embolization, major resistance occurred withdrawing the device causing peeling of the external frame of the microcatheter.An integrated portion of the microcatheter was found to aide in removal without leaving a fragment in the sma or the arc of riolan.A spasm was noticed at the beginning of the arc of riolan, with no prior functional repercussions.

• 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 ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13580853
• Report Number: 2134265-2022-01125
• Device Sequence Number: 5526809
• Product Code: KRA
• UDI-Device Identifier: 08714729839415
• UDI-Public: 08714729839415
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/20/2022

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: 07/05/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0027608193
• 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: 01/28/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 06/27/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/24/2022; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown