MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC XT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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

Patient Problems Hematoma (1884); Pericardial Effusion (3271); Ischemia Stroke (4418)

Event Date 04/01/2020

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 through a literature article that post cryoablation three patients experienced severe patient events.A non-boston scientific cryo balloon ablation (cba) procedure was performed under conscious sedation with propofol and analgesia with fentanyl, as required.A dynamic xt quadripolar catheter was used to confirm continuity of the phrenic nerve by pacing in the superior vena cava and continuous abdominal palpation during ablation of the right-sided pulmonary veins (rsdpvs).Transseptal puncture was performed guided by intracardiac echocardiography.The non-boston scientific cryoablation balloon (cb) was directed by means of a non-boston scientific steerable transseptal sheath.All analyzed cba procedures were performed with the 28-mm 2g-cb.A non-boston scientific multipolar mapping catheter was introduced for mapping of the pvs before and after ablation.The degree of pulmonary valve (pv) occlusion was evaluated by contrast injection after balloon inflation and placement and verified by pv angiography in the initial freezing period.Ablation was performed adherent to a two by 240-second freeze per vein protocol.To achieve complete occlusion, "hockey stick", "loop", and "pull-down" techniques were applied, if necessary.After "pull-down" maneuvers, the freezing time was prolonged by additional 240 seconds.In difficult cases, the balloon was repositioned, taking advantage of an alternative placement of the guiding catheter in another branch of the targeted pv.Adhering to our center-specific cba protocol, the left superior pulmonary vein (lspv) was isolated first, followed by the left inferior pulmonary vein (lipv), the right superior pulmonary vein (rspv), and the right inferior pulmonary vein (ripv).In case of insufficient isolation of all veins, application of the 23-mm balloon would have been a further option to reach the ripv or to isolate smaller veins.Ecg parameters were registered continuously.Pvi was confirmed 20 minutes later, adherent to the order of freezing with a non-boston scientific circular mapping catheter.Post cryoablation three patients experienced severe patient events.One patent experienced a hemodynamically relevant pericardial effusion, one patient experienced a stroke, and one patient experienced inguinal venous bleeding with the need for blood transfusion.No follow up information was presented on patient condition or treatment.Guckel d, schmidt a, gutleben kj, et al.Pulmonary vein isolation and beyond: predictive value of vagal reactions in second-generation cryoballoon ablation for the outcome of persistent atrial fibrillation.Heart rhythm.2020;17(4):600-606.

• Brand Name: DYNAMIC XT
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12017870
• MDR Text Key: 256797186
• Report Number: 2134265-2021-07808
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other