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

Lot Number 0028821162

Device Problem Leak/Splash (1354)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

It was reported that during a cryo-ablation procedure using a polarsheath, the patient experienced st segment elevation when the balloon catheter was inserted into the patient, through the sheath.They removed the balloon catheter and confirmed the elevation and there was blood leaking from the hemostatic valve.There was concern that air may have made it into the patient, however, no interventions were performed as the st elevation resolved spontaneously.Because the issue resolved on its own imaging was not able to be performed before it resolved, thus they could not confirm if air was present inside the patient.The procedure was completed with no further patient complications and no interventions.The sheath is expected to be returned for analysis.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory the sheath was first visually inspected which found nothing abnormal.Next, the sheath was put through procedural testing by replicating aspiration.The sheath passed this aspiration test as no air was visible in the flushing line any of the times the syringe was drawn.The next procedural test examined the hemostatic valve, which found the sheath was able to maintain pressure without any devices across the valve.Finally, they gently pressurized the sheath, while the distal tip was plugged, and the pressure decay value indicated a leak of the hemostatic valve.With all the available information boston scientific concludes the allegation of "air observed in the sheath" is confirmed.The kind of leak seen in the testing can lead to air being observed in the sheath during use.

Event Description

It was reported that during a cryo-ablation procedure using a polarsheath, the patient experienced st segment elevation when the balloon catheter was inserted into the patient, through the sheath.They removed the balloon catheter and confirmed the elevation and there was blood leaking from the hemostatic valve.There was concern that air may have made it into the patient, however, no interventions were performed as the st elevation resolved spontaneously.Because the issue resolved on its own imaging was not able to be performed before it resolved, thus they could not confirm if air was present inside the patient.The procedure was completed with no further patient complications and no interventions.The sheath has been received at boston scientific for analysis.

• Brand Name: POLARSHEATH
• 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: 15431037
• MDR Text Key: 304538735
• Report Number: 2124215-2022-36239
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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: 12/19/2022
• Device Lot Number: 0028821162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other