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

Lot Number 0028832054

Device Problem Leak/Splash (1354)

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

Event Date 07/22/2022

Event Type  malfunction  

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.

Event Description

It was reported that during a cryo ablation procedure using a polarsheath they observed air while they were checking blood flow.After the sheath was inserted into the patient's body they removed the dilator and guidewire, and when checking blood flow they observed air being withdrawn.They attempted to aspirate the air out of the sheath, however, they were unable to completely clear it.The sheath was exchanged and the procedure was completed without patient complications.The sheath has been received and is awaiting 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 failed this aspiration test as air was visible in the flushing line each time the syringe was drawn.The next procedural test examined the hemostatic valve, which found the sheath was not able to maintain pressure even when there was nothing across the valve.Finally they gently pressurized the sheath, while the distal tip was plugged, and the pressure decay value indicated a gross 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 they observed air while they were checking blood flow.After the sheath was inserted into the patient's body they removed the dilator and guidewire, and when checking blood flow they observed air being withdrawn.They attempted to aspirate the air out of the sheath, however, they were unable to completely clear it.The sheath was exchanged and the procedure was completed without patient complications.The sheath has been received at boston scientific's post market laboratory and analysis is completed.

• 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: 15165629
• MDR Text Key: 300902949
• Report Number: 2134265-2022-08364
• 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: 09/23/2022

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 Expiration Date: 12/20/2022
• Device Lot Number: 0028832054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 09/07/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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