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 Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)

Event Date 03/22/2021

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

(b)(6).It was reported that a poalrsheath and polarx were selected for a cryoablation procedure after a sheath exchange the patient developed inferolateral st elevation.It was noted that the patients blood pressure dropped and was "clammy".A echo was performed which excluded tamponade and showed good left ventricular contractility.The st elevation persisted and the decision was made to perform coronary angiography.Coronary angiography showed coronaries were normal and st elevation was settled.It was the clinical impression of an air embolism occurred.Ablation continued with no further complications occurred.The patient stayed over night and was discharged the next day.

• 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 DE COSTA RICA S.R.L.; 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: 11649200
• MDR Text Key: 244899054
• Report Number: 2134265-2021-04710
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M004CRBS3050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 107