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

Model Number	86706
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a dynamic xt electrode catheter was used in a tachycardia electrophysiological examination and radiofrequency ablation procedure.It was noted that the patient had a severely tortuous left femoral vein.Upon advancing to the junction of right femoral vein and inferior vena cava the blood vessel had angulation of 90 degrees, after pushing thought the angulation the catheter became stuck and was damaged.The catheter was replaced and the procedure was completed without patient complications.
Event or Problem Description
It was reported that a dynamic xt electrode catheter was used in a tachycardia electrophysiological examination and radiofrequency ablation procedure.It was noted that the patient had a severely tortuous left femoral vein.Upon advancing to the junction of right femoral vein and inferior vena cava the blood vessel had angulation of 90 degrees.After pushing thought the angulation the catheter became stuck and was damaged.The catheter was replaced and the procedure was completed without patient complications.It was further reported that the catheter's failure was that the catheter was unable to bend.The catheter was removed by simply pulling the catheter out without intervention.
Additional Manufacturer Narrative
The device was not returned for analysis and the complaint as reported could not be confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.
Additional Manufacturer Narrative
Visual inspection of the device showed no visible defects.Functional test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.Testing of the curve dimensions passed all testing; the curve is less than the maximum specification.The curve also passes the out-of-plane test.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that a dynamic xt electrode catheter was used in a tachycardia electrophysiological examination and radiofrequency ablation procedure.It was noted that the patient had a severely tortuous left femoral vein.Upon advancing to the junction of right femoral vein and inferior vena cava the blood vessel had angulation of 90 degrees.After pushing thought the angulation the catheter became stuck and was damaged.The catheter was replaced and the procedure was completed without patient complications.It was further reported that the catheter's failure was that the catheter was unable to bend.The catheter was removed by simply pulling the catheter out without intervention.

• Brand Name: DYNAMIC XT
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11913507
• Report Number: 2134265-2021-07065
• Device Sequence Number: 17200154
• Product Code: DRF
• UDI-Device Identifier: 08714729877622
• UDI-Public: 08714729877622
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K921872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2021

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: 10/17/2023
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0026204688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 09/02/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/07/2021; 09/20/2021
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 84