MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 86706

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During a radiofrequency ablation procedure, a dynamic xt electrode catheter was selected for use.It was reported that when the catheter was delivered into the branch of the vein, venous contracture occurred, and the catheter could not be withdrawn.The physician was eventually able to remove the catheter, and a different catheter was used to complete the procedure.No damage or patient complications were reported.

Manufacturer Narrative

The device was received at boston scientific for analysis.Visual inspection noted the returned dynamic xt catheter was cut in the catheter shaft at approximately 3cm from the plunger.The type of damage found indicates that possibly excessive force was applied over the device or bad manipulation during the procedure that caused the damage observed.The instructions for use addresses the vasospasm issue by stating: "the potential adverse events may be related to the diagnostic mapping catheter(s) and procedure, and/or interventional therapeutic device(s) and procedure.And that catheters be advanced or withdrawn when resistance is felt, without determining the cause.Vasospasm, valve damage, lead displacement, vascular and/or cardiac perforation and/or tamponade are risks with any intracardiac catheter." the reported event was confirmed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

Event Description

During a radiofrequency ablation procedure, a dynamic xt electrode catheter was selected for use.It was reported that when the catheter was delivered into the branch of the vein, venous contracture occurred, and the catheter could not be withdrawn.The physician was eventually able to remove the catheter, and a different catheter was used to complete the procedure.No further patient complications occurred.It was further reported that the venous contracture occurred in the iliac vein and above the femoral vein.No medications were given for treatment.The physician was able to remove the device by first fiddling with the tip of the device where he found the end warped.The physician thought that the possibility of incarceration was very high, so he cut the wire on the tail of the device, loosened the spring, and the tip of the device popped out.The problem was solved, and there was no tissue noted on the device after it was removed.

• Brand Name: DYNAMIC XT
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15941100
• MDR Text Key: 305074287
• Report Number: 2124215-2022-51009
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877622
• UDI-Public: 08714729877622
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K921872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0029552289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 55 KG