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

Model Number	80618
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: investigation completed on the returned device.Visual analysis revealed a fracture located 34.7cm from the hub.The device was not completely separated, as the inner liner was still attached.The fracture looked consistent with a bending force break.A.014 guidewire was inserted into the device but would not pass the kinked/fractured area of the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
Reportable based on analysis completed (b)(6) 2019.It was reported that the catheter was kinked.A direxion infusion catheter was selected for use.The catheter was inserted into the patient, however, it was kinked so the guidewire was unable to pass through the catheter.A second direxion infusion catheter was then selected, however, when it was removed out of the hoop it was stretched.A third direxion was used to complete the procedure successfully.There were no patient complications reported and the patient was stable post procedure.However, device analysis revealed a fracture located 34.7 cm from the hub.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8536226
• Report Number: 2134265-2019-04189
• Device Sequence Number: 19268442
• Product Code: KRA
• UDI-Device Identifier: 08714729839361
• UDI-Public: 08714729839361
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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: 11/12/2020
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 22930922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1