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

Model Number M004CRBS3050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 10/07/2020

Event Type  Injury  

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 Description

Clinical study (b)(6).It was reported that during or after a cryoablation procedure to treat atrial fibrillation with a polarsheath, the patient experienced slight bleeding at the puncture point.One new stitch was needed.The outcome of the event was ongoing.The device is not expected to be returned.No further information was provided.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Clinical study polar ice py003 it was reported that during or after a cryoablation procedure to treat atrial fibrillation, the patient experienced slight bleeding at the puncture point.One new stitch was needed.The outcome of the event was ongoing.The device is not expected to be returned.No further information was provided.It was further reported that the event resolved.

• 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: 10720045
• MDR Text Key: 212697033
• Report Number: 2134265-2020-14626
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025688907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 60