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

Model Number M004CRBS3050

Device Problem Material Integrity Problem (2978)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

During a procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that the sheath was deformed and seemed to be lifted.Sheath was prepared as usual and checked the curve.Puncture was performed and the sheath did not go properly when inserted.Doctor made an incision and widened the puncture site and tried to insert again.The tip was checked again and the damage was noted.The sheath was exchanged.The procedure was successfully completed with no patient complications.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was visually inspected which revealed a gouge in the body of the sheath's dilator which caused some of the dilator surface to be lifted, they also noted the tip of the dilator was deformed.In addition, a portion of the distal opening of the sheath was damaged and lifted.Next they inspected the interior of the sheath to investigate possible obstructions that could have lead to the damage observed on the dilator, however, no abnormalities were found that could contribute to the damage.Therefore, it could not be determined how and when the damage to the dilator occurred.As for the damage on the sheath itself, it is likely that the damage present on the dilator could have damaged the sheath opening when an attempt was made to retract the dilator during the procedure.The reported allegation was confirmed.

Event Description

During a procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that the sheath was deformed and seemed to be lifted.The sheath was prepared as usual and checked the curve.The puncture was performed and the sheath did not go in properly when inserted.The doctor made an incision and widened the puncture site and tried to insert again.The tip was checked again and the damage was noted.The sheath was exchanged.The procedure was successfully completed with no patient complications.

• Brand Name: POLARSHEATH
• 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: 14345827
• MDR Text Key: 295867003
• Report Number: 2134265-2022-05330
• Device Sequence Number: 1
• Product Code: DRA
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: M004CRBS3050
• Device Lot Number: 0028406915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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