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	12/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter broke.A 130 direxion transend-14 system was selected for use.During procedure, it was noted that the outer tubing of the microcatheter broke into two places upon navigation.No patient complications reported.
Event or Problem Description
It was reported that the microcatheter broke.A 130 direxion transend-14 system was selected for use.During procedure, it was noted that the outer tubing of the microcatheter broke into two places upon navigation.No patient complications reported.It was further reported that the target lesion was in the urinary bladder.The inner tubing was intact allowing to remove the catheter from the patient and the procedure was completed with a different device.
Additional Manufacturer Narrative
E1.Initial reporter first name updated.E1.Initial reporter email updated.
Additional Manufacturer Narrative
E1.Initial reporter first name updated.E1.Initial reporter email updated.Device evaluated by manufacturer: the device was returned for analysis.The device had traces of blood on it.Inspection revealed outer shaft fracture located 9.8cm and 10cm from the strain relief, and inner shaft damage (twisted/flattened).Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that the microcatheter broke.A 130 direxion transend-14 system was selected for use.During procedure, it was noted that the outer tubing of the microcatheter broke into two places upon navigation.No patient complications reported.It was further reported that the target lesion was in the urinary bladder.The inner tubing was intact allowing to remove the catheter from the patient and the procedure was completed with a different device.

• 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: 9610480
• Report Number: 2134265-2020-00263
• Device Sequence Number: 16274700
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: 08714729839774
• Combination Product (Y/N): N
• Initial Reporter Country: AE
• 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,Followup
• Report Date (Section B): 03/03/2020

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: 07/11/2021
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0024095358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 12/28/2019
• Supplement Date Received by Manufacturer: 01/29/2020; 02/26/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/19/2020; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1