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 Arrhythmia (1721); Chest Pain (1776); Dyspnea (1816); Sweating (2444); Diaphoresis (2452); Chest Tightness/Pressure (2463); Palpitations (2467)

Event Date 10/18/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Clinical study (b)(6).It was reported that following an ablation procedure with a polarx balloon catheter, the patient presented to the emergency room (er) with chest pain that started 30 minutes prior, shortness of breath (sob), was clammy, experienced heaviness and his heart skipping beats.The patient was in hospital and will update as visits continue.The patient had blood work performed and was given oral cardizem and intravenous (iv) / intramuscular (im) lasix.The event then resolved with no sequalae.The ablation procedure was listed as what probably caused the event.The device is not expected to be returned for analysis.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

Clinical study frozen af py004.It was reported that following an ablation procedure with a polarx balloon catheter, the patient presented to the emergency room (er) with chest pain that started 30 minutes prior, shortness of breath (sob), was clammy, experienced heaviness and his heart skipping beats.The patient was in hospital and will update as visits continue.The patient had blood work performed and was given oral cardizem and intravenous (iv) / intramuscular (im) lasix.The event then resolved with no sequalae.The ablation procedure was listed as what probably caused the event.The device is not expected to be returned for analysis.It was further reported that additional corrective actions were taken.The patient was given 1mg of ativan intravenous (iv)/intramuscular (im), morphine iv/im and lorazepam iv/im.

• 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: 11124973
• MDR Text Key: 225329766
• Report Number: 2134265-2021-00040
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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: 07/05/2021
• Device Model Number: M004CRBSUSC3050
• Device Lot Number: 0025908461
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/16/2021
• Patient Sequence Number: 1
• Treatment: "SYPER SHEATH"; "SYPER SHEATH"; POLARSHEATH; POLARSHEATH; "SYPER SHEATH"; POLARSHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 114