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

Model Number	80618
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.Returned product consisted of a direxion micro-catheter.The shaft was visually examined.The device showed damage in the form of a fracture located at 58cm from the hub.The device was not completely separated the inner liner was still attached.There was no evidence of a kink on the catheter 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 device analysis completed on 20-dec-2018.It was reported that the device was kinked.The target lesion was located in the tortuous left internal iliac artery.A 130cm direxion was selected for use.During procedure, the.035 glide catheter was advanced into the lesion and then the direxion catheter was inserted through the glide catheter with the fathom wire.Subsequently, the direxion catheter was kinked during manipulation and navigation through the tortuous anatomy.The procedure was completed with a different device.No patient complications reported.However, device analysis revealed a device fracture at 58cm 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: 8246942
• Report Number: 2134265-2018-65085
• Device Sequence Number: 1607536
• Product Code: KRA
• UDI-Device Identifier: 08714729839385
• UDI-Public: 08714729839385
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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: 08/07/2020
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0022485223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER- .035 GLIDE CATHETER; GUIDEWIRE- FATHOM