MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO TRANSEND-18 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84593
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer shaft of the catheter was broken and detached.A direxion hi-flo transend-18 system was selected for use.During the procedure, when the microcatheter was introduced through a non-bsc device with the transend 18 guidewire, the outer shaft of the microcatheter broke and detached.The device was replaced and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the outer shat of the catheter was broken and detached.A direxion hi-flo transend-18 system was selected for use.During the procedure when the microcatheter was introduced through a non bsc device with the transend 18 guidewire, the outer shaft of the microcatheter broke and detached.The device was replaced and the procedure was completed with another of the same device.No patient complications were reported.Device evaluated by mfr.: the device was returned for evaluation.A microscopic examination of the shaft revealed damage in the form of fractured shafts in 2 locations.The 1st location was 56.2cm from the hub and the 2nd location was 59.5cm from the hub.The device was not completely separated the inner liner was still attached.The shaft showed a kink 21.4cm from the tip.This device is compatible with a 5fr guide catheter which is stated in the customers returned statement as the catheter used.No other damage or irregularities noted during product analysis.

• Brand Name: DIREXION HI-FLO TRANSEND-18 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7918663
• Report Number: 2134265-2018-61397
• Device Sequence Number: 2014692
• Product Code: KRA
• UDI-Device Identifier: 08714729839842
• UDI-Public: 08714729839842
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/10/2018

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: 11/14/2019
• Device Model Number: 84593
• Device Catalogue Number: 84593
• Device Lot Number: 0021383977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR