MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARMAP; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 0033212500

Device Problem Difficult to Remove (1528)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported that the catheter was trapped in the balloon catheter.During a pulmonary vein isolation (pvi) ablation procedure, a polarmap catheter was selected for use.After having prepared polarxfit balloon properly, soon after ablation started, temperature did not decrease and physician noticed that the catheter handle was getting cooler.Ablation was stopped after a few seconds and noticed that gas cable connection was frozen, probably because some water was present during preparation and it was not noticed.Then, it was noticed that the polarmap was trapped in the balloon, when pulling it outside the patient, it was noticed that the catheter was frozen.The handle and the proximal portion of the polarx shaft were frozen.Finally, it was decided to replace the polarxfit and the polarmap and the issue was resolved.Procedure was completed successfully without any patient complications.Both devices are being returned for further analysis.

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.

Manufacturer Narrative

Initial reporter phone: (b)(6) the polarmap was evaluated by boston scientific.The polarmap was visually inspected for any damage related to the reported complaint seen in the field.No physical damage or defects were noted.The returned polarmap was inserted into a known good catheter.Inserting and removing the polarmap had the expected amount of resistance.Laboratory analysis was unable to confirm the reported clinical observation of difficult to remove.Device was found within specifications.

Event Description

It was reported that the catheter was trapped in the balloon catheter.During a pulmonary vein isolation (pvi) ablation procedure, a polarmap catheter was selected for use.After having prepared polarxfit balloon properly, soon after ablation started, temperature did not decrease and physician noticed that the catheter handle was getting cooler.Ablation was stopped after a few seconds and noticed that gas cable connection was frozen, probably because some water was present during preparation and it was not noticed.Then, it was noticed that the polarmap was trapped in the balloon, when pulling it outside the patient, it was noticed that the catheter was frozen.The handle and the proximal portion of the polarx shaft were frozen.Finally, it was decided to replace the polarxfit and the polarmap and the issue was resolved.Procedure was completed successfully without any patient complications.Device was returned for laboratory analysis.

• Brand Name: POLARMAP
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• 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: 19145304
• MDR Text Key: 341063771
• Report Number: 2124215-2024-23259
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/23/2024

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 Lot Number: 0033212500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1