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	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke.A direxion hi-flo was selected for use.Upon withdrawal, it was noted that the device broke.No patient complications were reported.
Event or Problem Description
It was reported that the device broke.A direxion hi-flo was selected for use.Upon withdrawal, it was noted that the device broke.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The tip, inner and outer shafts, and the hub/strain relief were microscopically and visually inspected.Inspection revealed a complete separation of both the inner and outer shaft at the base of the hub/strain relief, with the inner shaft damaged (stretched and flattened) for a length of 92mm with numerous kinks in the exposed inner shaft.Inspection of the rest of the catheter found no other damage or irregularities.

• 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: 8740529
• Report Number: 2134265-2019-07497
• Device Sequence Number: 2637755
• Product Code: KRA
• UDI-Device Identifier: 08714729839569
• UDI-Public: 08714729839569
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/29/2019

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: 07/26/2019
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0020931661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1