MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION TRANSEND-14 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84590
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that micro catheter was fractured.The target lesion was located in the hepatic artery.A direxion transend-14 system was selected for use.During procedure, intra-abdominal angiography of the hepatic duct that went deep into the distal common hepatic artery was performed.The microcatheter was used to perform angiogram into the branch of the proper hepatic artery, however the proximal end of the device was fractured during several injections of the microsphere.The device was then simply pulled out completely from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip, inner/outer shaft, and hub included microscopic and visual inspection.Inspection revealed the outer shaft separated 1mm from the strain relief with the inner shaft damaged (flattened) in between the fracture faces.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that micro catheter was fractured.The target lesion was located in the hepatic artery.A direxion transend-14 system was selected for use.During procedure, intra-abdominal angiography of the hepatic duct that went deep into the distal common hepatic artery was performed.Subsequently, the microcatheter was used to perform angiogram into the branch of the proper hepatic artery, however the device was fractured during several injections of the microsphere.The device was then simply pulled out completely from the patient's body.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: DIREXION TRANSEND-14 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10379022
• Report Number: 2134265-2020-10622
• Device Sequence Number: 19260463
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: 08714729839774
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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 Expiration Date: 04/27/2022
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0025471264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 58