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

Model Number	80619
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located in the severely tortuous and non-calcified inferior mesenteric artery.A straight/130 direxion hi-flo catheter-fusion was selected for use.During the procedure, the device was inserted into a 5 french non-boston scientific angiographic catheter but could not be inserted further from the middle and it got stuck.The device was removed from the angiographic catheter by pulling it hard as there were severe resistance encountered.A kink was noted when the device was removed.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed 1 fracture located 118.5cm from the hub.The shaft was not completely separated the inner liner was still connected.No other damage was noticed on the catheter shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No kinks were confirmed; however, a fracture was confirmed.
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located in the severely tortuous and non-calcified inferior mesenteric artery.A straight/130 direxion hi-flo catheter-fusion was selected for use.During the procedure, the device was inserted into a 5 french non-boston scientific angiographic catheter but could not be inserted further from the middle and it got stuck.The device was removed from the angiographic catheter by pulling it hard as there were severe resistance encountered.A kink was noted when the device was removed.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: DIREXION HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12447250
• Report Number: 2134265-2021-11194
• Device Sequence Number: 3382845
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 04/22/2023
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0027190720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1