MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV ST; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	87069
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Intellanav st catheter was evaluated by boston scientific corporation.Visual inspection noted that the device presents a twist in the distal part of the catheter shaft and is broken in the proximal part of the catheter shaft.A functional test was performed, and the test shows that the plunger functioned properly.No abnormal resistance was felt when actuating the steering mechanism.Finally, a dimensional test was done, and the device did not meet one of the curves reached.Laboratory analysis was able to confirm the reported clinical observations.
Event or Problem Description
Reportable based on analysis completed on 05jan2023.It was reporter that during procedure to treat paroxysmal supraventricular tachycardia in the tricuspid annulus, an intellanav st catheter was selected for use.Durring the procedure the catheter was deformed.The catheter was replaced, and the issue was resolved.Procedure was able to be completed successfully without any complications.Catheter was returned to boston scientific corporation for laboratory analysis.Product investigation revealed a break in the proximal part of the catheter shaft.

• Brand Name: INTELLANAV ST
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 16253767
• Report Number: 2124215-2023-02783
• Device Sequence Number: 5350681
• Product Code: LPB
• UDI-Device Identifier: 08714729963974
• UDI-Public: 08714729963974
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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: 08/05/2024
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0027793017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 60 KG