MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE

Model Number M004CRBS3050

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

Patient Problem Headache (1880)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

(b)(6) clinical study.Index ablation procedure was performed on (b)(6) 2021.It was reported that the patient experienced migraine following polarx cryoablation ablation involving a polarsheath.The suspected cause was due the transdermal puncture.On (b)(6) 2021, sumatriptan was prescribed.The event is still ongoing and have not been resolved.

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.There is no evidence this device was used in a manner inconsistent with the labeled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

Polar ice clinical study, subject id: (b)(4).Index ablation procedure was performed on (b)(6) 2021.It was reported that the patient experienced migraine following polarx cryoablation ablation involving a polarsheath.The suspected cause was due the transdermal puncture.On 21may2021, sumatriptan was prescribed.The event is still ongoing and have not been resolved.Additional information received indicated that the event was resolved on 18may2021.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 12063172
• MDR Text Key: 258318764
• Report Number: 2134265-2021-08124
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026639544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 93 KG