MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; VASCULAR GUIDE CATHETER, SINGLE-USE

Model Number	M004CRBS3150
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure to treat an atrial fibrillation, a crbs polarsheath was selected for use, however after the sheath was inserted and the dilator was removed, when trying to aspirate the sheath, air was seen.It is unknown if the stopcock was at the correct orientation at the time of aspiration, but there was no fluid in the side port either.The physician had trouble with transseptal.Therefore, it was decided to replace the device and the issue was resolved.The procedure was completed.No patient complications were reported.The device is not expected to return, it was discarded at the facility.
Additional Manufacturer Narrative
Udi related data quality updates only.This report is being filed as a correction in response to an fda request for the complete unique identifier (udi) # and to correct discrepancies with product information in the gudid database.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure to treat an atrial fibrillation, a crbs polarsheath was selected for use, however after the sheath was inserted and the dilator was removed, when trying to aspirate the sheath, air was seen.It is unknown if the stopcock was at the correct orientation at the time of aspiration, but there was no fluid in the side port either.The physician had trouble with transseptal.Therefore, it was decided to replace the device and the issue was resolved.The procedure was completed.No patient complications were reported.The device is not expected to return, it was discarded at the facility.

• Brand Name: POLARSHEATH
• Common Device Name: VASCULAR GUIDE CATHETER, SINGLE-USE
• 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: 17853433
• Report Number: 2124215-2023-52660
• Device Sequence Number: 3352980
• Product Code: DRA
• UDI-Device Identifier: 00191506039776
• UDI-Public: (01)00191506039776(17)240704(10)31951675
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2024
• Device Model Number: M004CRBS3150
• Device Catalogue Number: M004CRBS3150
• Device Lot Number: 0031951675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown