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

Model Number	84590
Medical Device Problem Codes	Mechanical Problem (1384); Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image were not clear under fluoroscopy.The target lesion was located in the hepatic artery.A direxion transend-14 system was selected for use.During the procedure, the microcatheter with poor liquidity was advance into the microvasculature with the help of the rh catheter.The 2ml contrast was injected with difficulty.Even with high-pressure syringe to inject the contrast, the image was not clear, and it was noted that the catheter could hardly be seen.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was microscopically analyzed for any damage.No shaft damage was noticed.The device was x-rayed and showed no obstruction.The tip was x-rayed, and the marker band was noticeable on the device.Fluid was injected through the device and showed the lumen was patent, and no obstruction was confirmed.A.014 test guidewire was inserted into the devices lumen to confirm the lumen patency.No obstructions were noticed.A torque test was completed by applying a piece of tape to the tip of the device.The shaft was rotated to see what response the tip may have.The tip turned 1 for 1 during a 360 degree turn of the catheter shaft.No issues on the torque were noticed.Inspection of the remainder of the device revealed no damage or irregularities.The device was not confirmed for obstruction or not identifying the tip under x-ray.
Event or Problem Description
It was reported that the image were not clear under fluoroscopy.The target lesion was located in the hepatic artery.A direxion transend-14 system was selected for use.During the procedure, the microcatheter with poor liquidity was advance into the microvasculature with the help of the rh catheter.The 2ml contrast was injected with difficulty.Even with high-pressure syringe to inject the contrast, the image was not clear, and it was noted that the catheter could hardly be seen.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15437983
• Report Number: 2124215-2022-35260
• Device Sequence Number: 12223580
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 09/22/2023
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0028065840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 48 KG