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

Lot Number 0029900306

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

Patient Problems Dyspnea (1816); Fistula (1862); Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 03/03/2023

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

Polar smart clinical study, clinical study id: py007, subject id: (b)(4).It was reported that following a cryoablation procedure using a polarsheath the patient experienced shortness of breath and bleeding at the access site, in addition an arteriovenous fistula was diagnosed.The shortness of breath and bleeding were reported by the patient on (b)(6) 2023 and they were admitted to the hospital on (b)(6) 2023.A thrombin injection was administered after admission.It was also noted that a duplex ultrasound was performed, a complete blood count blood test was done, and x-rays were taken.While in hospital patient's blood pressure decreased and a blood transfusion was administered.An arteriovenous fistula was diagnosed and removed while in the hospital.The original procedure had been completed, and the current issue is considered to be ongoing.The sheath is not expected to be returned as the adverse event occurred after the procedure was done.

• Brand Name: POLARSHEATH
• Type of Device: 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: 16682851
• MDR Text Key: 312708246
• Report Number: 2124215-2023-14586
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2023
• Device Lot Number: 0029900306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 62 KG