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

Model Number 84590

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device shaft was microscopically analyzed for any damage.The devices shaft showed a fractured shaft located 124.7cm from the hub.The device also showed bend damage located 125cm from the hub to the tip.The device was not completely separated the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.A fractured and bent shaft was confirmed.

Event Description

Reportable based on device analysis completed on 05dec2023.It was reported that the coil could not advance inside the catheter and got kinked after removed.The target lesion was located in the internal iliac artery.The direxion transend-14 system was selected for use.During the procedure, the catheter was not in a correct position as the physician was not satisfied on the initial placement of the coil.The physician withdrawn the device and after being flushed with heparin saline, it was deployed again, however, it was noted that the coil could not be advance inside the tail end of the catheter.The device was removed by following the contrast directly out of the body.When checked after removal, it was found that the microcatheter was kinked.The procedure completed with another of same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the shaft was fractured 124.7cm from the hub.

• Brand Name: DIREXION TRANSEND-14 SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18380095
• MDR Text Key: 331374108
• Report Number: 2124215-2023-71931
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839774
• UDI-Public: 08714729839774
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0029769170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 62 KG