MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. SMARTFREEZE CRYOABLATION CABLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Lot Number 0031545854

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

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

It was reported that prior to a cryo pulmonary vein isolation (pvi) procedure to treat atrial fibrillation a smartfreeze cryoablation cable was selected for use.After connection of the cryo gas cable and the polarxfit catheter, the error message sn (b)(6): the outer balloon pressure is too high appeared on the cryo console during the initial balloon inflation.The cryo gas cable was disconnected then reconnected, and was also replaced, but the error still repeated after each of these attempted fixes.The catheter was replaced, but the error continued.After that the electrical extension cable was replaced, but the error still continued.The cryo console was replace with another from a nearby public hospital, but the outer balloon pressure (obp) error occurred again.The error continued even after connecting the second cryo console to different scavenge ports as well.With no resolution to the repeated obp errors, the procedure was cancelled.The device is expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.

Manufacturer Narrative

The smartfreeze cryoablation cable was returned to boston scientific for analysis.Upon receipt at the post market quality assurance laboratory the cable underwent visual inspection, leakage testing, and functional testing.No damage or abnormalities were visually observed.The device was connected to the smartfreeze gold system in attempt to recreate the error observed in the field.The device was assessed with an isaac pressure decay system to determine if any potential leak paths existed and it gross leaked on the high pressure for both ends.The device was connected to the smartfreeze gold system in attempt to recreate the error observed in the field.A 120 second ablation was attempted on each end however, an obp error occurred when inflating the balloon.The reported clinical observations were confirmed.

Event Description

It was reported that prior to a cryo pulmonary vein isolation (pvi) procedure to treat atrial fibrillation a smartfreeze cryoablation cable was selected for use.After connection of the cryo gas cable and the polarxfit catheter, the error message sn (b)(6): the outer balloon pressure is too high appeared on the cryo console during the initial balloon inflation.The cryo gas cable was disconnected then reconnected, and was also replaced, but the error still repeated after each of these attempted fixes.The catheter was replaced, but the error continued.After that the electrical extension cable was replaced, but the error still continued.The cryo console was replace with another from a nearby public hospital, but the outer balloon pressure (obp) error occurred again.The error continued even after connecting the second cryo console to different scavenge ports as well.With no resolution to the repeated obp errors, the procedure was cancelled.The device is expected to be returned for analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: SMARTFREEZE CRYOABLATION CABLE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 18345022
• MDR Text Key: 331073340
• Report Number: 2124215-2023-71086
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Lot Number: 0031545854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1