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	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip was broken.A direxion hi flo infusion catheter and non-bsc guidewire wire were selected for use in a prostate embolization procedure.After the direxion catheter had been inserted into the patient, the non-bsc guidewire was inserted into the catheter.The physician felt something unusual and decided to remove both the catheter and guidewire.The proximal tip of the catheter was damaged.The inner layer appeared broken.A new device, same model, was selected to complete the procedure.The patient experienced no adverse effects and was stable post procedure.
Event or Problem Description
It was reported that the tip was broken.A direxion hi flo infusion catheter and non-bsc guidewire wire were selected for use in a prostate embolization procedure.After the direxion catheter had been inserted into the patient, the non-bsc guidewire was inserted into the catheter.The physician felt something unusual and decided to remove both the catheter and guidewire.The proximal tip of the catheter was damaged.The inner layer appeared broken.A new device, same model, was selected to complete the procedure.The patient experienced no adverse effects and was stable post procedure.
Additional Manufacturer Narrative
Device analysis by mfr: the returned product consisted of a direxion hi flo microcatheter with a y-connector on the sheath/device.Inspection revealed the outer shaft fractured 6.6 cm from the tip with the inner shaft stretched in-between the outer fracture.Inspection of the rest of the device found no other damage or defect.

• 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: 9453213
• Report Number: 2134265-2019-15410
• Device Sequence Number: 19605714
• Product Code: KRA
• UDI-Device Identifier: 08714729839576
• UDI-Public: 08714729839576
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/16/2020

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 Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0023591705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT HI-TORQUE COMMAND PERIPHERAL GUIDEWIRE; ABBOTT HI-TORQUE COMMAND PERIPHERAL GUIDEWIRE