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

Model Number 86706

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/03/2021

Event Type  malfunction  

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

It was reported that a dynamic xt was selected to be used in a atrioventricular nodal reentry tachycardia (avnrt) ablation procedure.Prior to the procedure it was noted that the catheter snapped before use in a patient.The catheter was replaced and the procedure was completed with no patient complications being reported.

Manufacturer Narrative

Visual inspection of the device showed the plunger broken from the handle.Functional and dimensional test can not be performed due to the condition of the plunger.During microscopic inspection it was noted that the plunger was broken.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

It was reported that a dynamic xt was selected to be used in a atrioventricular nodal reentry tachycardia (avnrt) ablation procedure.Prior to the procedure it was noted that the catheter snapped before use in a patient.The catheter was replaced and the procedure was completed with no patient complications being reported.

• 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: 12917403
• MDR Text Key: 281607099
• Report Number: 2134265-2021-15232
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877615
• UDI-Public: 08714729877615
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 86706
• Device Catalogue Number: 86706
• Device Lot Number: 0027449465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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