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

Model Number	80619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a catheter separation occurred.The target lesion was located in the moderately tortuous superior mesenteric artery (sma).A 130 direxion hi-flo was selected for use in embolization.After delivering the wire to the sma, the direxion was applied to the blood vessel.The direxion went out from the target vessel, so, it was attempted to engage again.When trying to change the direction of the catheter tip by applying torque, discomfort was felt.When the wire and catheter were pulled out, it was noted that the outer side of the direxion catheter got separated/broken off, but the inner liner was still connected (not separated).The devices were able to remove from the patient by simply pulling out and no fragment remained.The procedure was completed with a different device.There were no complications reported and the patient was good post procedure.
Additional Manufacturer Narrative
E1- initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed the outer shaft had fractured 54.3cm from the strain relief, and the inner shaft had kinked in between the fracture faces.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that a catheter separation occurred.The target lesion was located in the moderately tortuous superior mesenteric artery (sma).A 130 direxion hi-flo was selected for use in embolization.After delivering the wire to the sma, the direxion was applied to the blood vessel.The direxion went out from the target vessel, so, it was attempted to engage again.When trying to change the direction of the catheter tip by applying torque, discomfort was felt.When the wire and catheter were pulled out, it was noted that the outer side of the direxion catheter got separated/broken off, but the inner liner was still connected (not separated).The devices were able to remove from the patient by simply pulling out and no fragment remained.The procedure was completed with a different device.There were no complications reported and the patient was good post procedure.

• 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: 10174552
• Report Number: 2134265-2020-08240
• Device Sequence Number: 2924452
• Product Code: KRA
• UDI-Device Identifier: 08714729839545
• UDI-Public: 08714729839545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 02/25/2022
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0025270589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1