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 Problems Atrial Fibrillation (1729); Fever (1858); Hemoptysis (1887); Pneumonia (2011)

Event Date 11/28/2020

Event Type  Injury  

Manufacturer Narrative

Weight: (b)(6).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 day following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient felt unwell, went to the local emergency department and was hospitalized.An electrocardiogram (ecg) showed atrial fibrillation (af).He was noted to also have hemoptysis and a fever.The patient was given amiodarone and went back into sinus rhythm (sr) the next day.Two days later, the patient went back into af but reverted back to sr on the same day.A diagnosis of right sided community acquired pneumonia and infection driven atrial fibrillation recurrence was made.The patient was discharged two days later.The event outcome was reported as ongoing.The devices are not expected to be returned for analysis.

Event Description

Clinical study polar ice py003 it was reported that day following a cryoablation procedure with a polarx balloon catheter and polarsheath, the patient felt unwell, went to the local emergency department and was hospitalized.An electrocardiogram (ecg) showed atrial fibrillation (af).He was noted to also have hemoptysis and a fever.The patient was given amiodarone and went back into sinus rhythm (sr) the next day.Two days later, the patient went back into af but reverted back to sr on the same day.A diagnosis of right sided community acquired pneumonia and infection driven atrial fibrillation recurrence was made.The patient was discharged two days later.The event outcome was reported as ongoing.The devices are not expected to be returned for analysis.It was further reported that the event resolved.

Manufacturer Narrative

A.4.Weight: 88.5 kg.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.

• 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: 11132776
• MDR Text Key: 225574085
• Report Number: 2134265-2020-18848
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2021
• Device Model Number: M004CRBS3050
• Device Lot Number: 0025850016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: POLARX; POLARX; POLARX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male