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 Abdominal Pain (1685); Dyspnea (1816)

Event Date 03/08/2021

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 following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient experienced dyspnea with pain in the upper stomach.The suspected cause was reported as "acute erosive gastritis." the event resulted in in-person hospitalization and/or prolongation of an existing hospitalization.The diagnostics performed were an electrocardiogram (ecg), x-ray, laboratory work (i.E.Bloodwork), ultrasound/echocardiogram/transesophageal echocardiogram (tee)/transesophageal echocardiogram (tte) and a gastroscopy.No corrective actions were taken and the event resolved.No further information was provided.The device is not expected to be returned for analysis.

• 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 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: 11582172
• MDR Text Key: 242724823
• Report Number: 2134265-2021-04027
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0026187891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: POLARX
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 67