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

Model Number	M0046DYNTP0010
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
"**udi related data quality updates only** this report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." 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).

• Brand Name: DYNAMIC TIP STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: 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
• Report Number: 2124215-2023-66966
• Device Sequence Number: 17919199
• Product Code: DRF
• UDI-Device Identifier: 08714729879848
• UDI-Public: (01)08714729879848(17)20260803(10)0032154627
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K912213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2026
• Device Model Number: M0046DYNTP0010
• Device Catalogue Number: 86702
• Device Lot Number: 0032154627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 07/09/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/18/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG