MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

Model Number M004CRBS3050

Device Problem Difficult to Remove (1528)

Patient Problem Hematoma (1884)

Event Date 10/06/2020

Event Type  Injury  

Event Description

It was reported that a polarx cryo ablation balloon catheter was used in a pulmonary vein isolation procedure.After the transseptal puncture performed the polarsheath , polarmap and polarx were then prepared and inserted successfully.The target lesion of the left superior pulmonary vein grade 4 occlusion was then ablated successfully.The physician then moved onto the left interior pulmonary vein with a grade 3-4 occlusion which was also performed successfully.The physician then moved to the right side of the heart to right superior pulmonary vein when a blood detection error (error 1 - 00004000-2) occurred after inflation.The polarx was deflated using the slider switch, removed from the polar sheath and the polarx and cryo-cables were replaced.A new polarx catheter and cryo-cable was connected and a blood detection error occurred again while balloon outside of patient.The cryo-cable was disconnected and reconnected.Then the polar x was prepped and inserted into the polar sheath without any issues.The ablation of the right superior pulmonary vein was performed successfully with no issues to the pacing of the phrenic nerve.The physician then encountered difficulties positioning the polarx at the right inferior pulmonary vein(ripv) while targeting ripv, potential air embolism as noticed by st segment elevation on ecg occurred.The polarx was removed from the polarsheath and a coronary sinus catheter was used to find the ripv.Once the ripv signals were found the cs catheter was switched out for the polarx.When the polarx was reinserted into the polarsheath during inflation the blood detection error occurred again.The polarx was deflated using the slider switch but the physician noticed that the balloon was stuck in the polarsheath.The polarx was then re-inflated then deflated with the slider switch however was still unable to removed.The physician then asked for another physician for help, it was then noticed that the proximal shaft of catheter was kinked.While trying to remove the polarsheath and the catheter from the left atrium, they "slipped" into the right atrium.When they tried to remove polarsheath and catheter from patient, they discovered that the balloon and tip were no longer attached to catheter shaft, it was also noted that there was blood in the cryo-cable.Fluoroscopy imaging showed that balloon was stuck in femoral vein.The balloon and tip were successfully removed from the femoral vein of patient by vascular surgical team.It was noted that post procedure the patient developed hematomas after the procedure, which were treated.The patient was monitored overnight, and was reported to be doing better.However, the patient will continue to be monitored.

Manufacturer Narrative

Device technical analysis: the returned device was returned with the dilator inside the sheath and the right on the end of the puller wire is bent at the distal end.On the distal end of the sheath the radiopaque marker band is damaged and protrudes into the inner diameter of the shaft.The valve of the device did not show sines of sharp edges or protrusions.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that a polarx cryo ablation balloon catheter was used in a pulmonary vein isolation procedure.After the transseptal puncture performed the polarsheath , polarmap and polarx were then prepared and inserted successfully.The target lesion of the left superior pulmonary vein grade 4 occlusion was then ablated successfully.The physician then moved onto the left interior pulmonary vein with a grade 3-4 occlusion which was also performed successfully.The physician then moved to the right side of the heart to right superior pulmonary vein when a blood detection error(error 1 - 00004000-2) occurred after inflation.The polarx was deflated using the slider switch, removed from the polar sheath and the polarx and cryo-cables were replaced.A new polarx catheter and cryo-cable was connected and a blood detection error occurred again while balloon outside of patient.The cryo-cable was disconnected and reconnected.Then the polar x was prepped and inserted into the polar sheath without any issues.The ablation of the right superior pulmonary vein was performed successfully with no issues to the pacing of the phrenic nerve.The physician then encountered difficulties positioning the polarx at the right inferior pulmonary vein(ripv) while targeting ripv, potential air embolism as noticed by st segment elevation on ecg occurred.The polarx was removed from the polarsheath and a coronary sinus catheter was used to find the ripv.Once the ripv signals were found the cs catheter was switched out for the polarx.When the polarx was reinserted into the polarsheath during inflation the blood detection error occurred again.The polarx was deflated using the slider switch but the physician noticed that the balloon was stuck in the polarsheath.The polarx was then re-inflated then deflated with the slider switch however was still unable to removed.The physician then asked for another physician for help, it was then noticed that the proximal shaft of catheter was kinked.While trying to remove the polarsheath and the catheter from the left atrium, they "slipped" into the right atrium.When they tried to remove polarsheath and catheter from patient, they discovered that the balloon and tip were no longer attached to catheter shaft, it was also noted that there was blood in the cryo-cable.Fluoroscopy imaging showed that balloon was stuck in femoral vein.The balloon and tip were successfully removed from the femoral vein of patient by vascular surgical team.It was noted that post procedure the patient developed hematomas after the procedure, which were treated.The patient was monitored overnight, and was reported to be doing better.However, the patient will continue to be monitored.

• Brand Name: POLARSHEATH
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 10778904
• MDR Text Key: 214407448
• Report Number: 2134265-2020-15209
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025710273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention