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

Model Number 86702

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 the tip of the device was fractured.During a radiofrequency ablation procedure, a dynamic tip electrode catheter was selected for use.It was reported that the junction of the catheter was kinked.Also, when unpacking the device, it was noticed the tip of the catheter was fractured.Device was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter is expected to be returned for further analysis.

Manufacturer Narrative

Dynamic tip electrode catheter was evaluated by boston scientific.Analysis of returned product revealed that the unit showed no evidence or defects that could have contributed to the tip damaged-kinked event; consequently, not confirming the reported clinical observation of tip fracture.However, during the product analysis it was observed that the plunger of the device was broken.The cause of the issue seen in the field could not be determined.Initial reporter phone: (b)(6).

Event Description

It was reported that the tip of the device was fractured.During a radiofrequency ablation procedure, a dynamic tip electrode catheter was selected for use.It was reported that the junction of the catheter was kinked.Also, when unpacking the device, it was noticed the tip of the catheter was fractured.Device was replaced and the issue was resolved.Procedure was able to be completed successfully without any patient complications.Catheter was returned to boston scientific for laboratory analysis.

• Brand Name: DYNAMIC TIP STEERABLE DIAGNOSTIC CATHETER
• 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: 18242084
• MDR Text Key: 330561266
• Report Number: 2124215-2023-66966
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729879848
• UDI-Public: 08714729879848
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K912213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: 86702
• Device Catalogue Number: 86702
• Device Lot Number: 0032154627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG