MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004CRBSUSC3050

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

Patient Problems Hemoptysis (1887); No Code Available (3191); Cough (4457)

Event Date 01/06/2021

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

It was reported that a polarx and polarsheath were used in a procedure on (b)(6) 2020.On 6jan2021 it was reported that the patient has had a continued dry cough since the procedure which as been improving but remains.The patient also has had two episodes of hemoptysis after performing vigorous activity.Per the physician the suspected cause is bronchial injury or lung necrosis.

Event Description

It was reported that a polarx and polarsheath were used in a procedure on (b)(6) 2020.On (b)(6) 2021 it was reported that the patient has had a continued dry cough since the procedure which as been improving but remains.The patient also has had two episodes of hemoptysis after performing vigorous activity.Per the physician the suspected cause is bronchial injury or lung necrosis.It was further reported that the ablation procedure was not related to the patient condition.

Manufacturer Narrative

The device was not returned for analysis and the complaint as reported could not be confirmed.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.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 11239842
• MDR Text Key: 229091431
• Report Number: 2134265-2021-00892
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2021
• Device Model Number: M004CRBSUSC3050
• Device Lot Number: 0025586094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 100