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 Death (1802); Hemorrhage/Bleeding (1888); Renal Failure (2041); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 07/31/2019

Event Type  Death  

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 the patient experienced a perforation in the left atrium of the heart.During a cardiac ablation procedure for atrial fibrillation, after mapping with an intellamap orion catheter and while ablating with an intellanav mifi oi large curve catheter, it was realized that the patient had a perforation in the left atrium.The patient was bleeding and underwent emergency surgical repair.The surgery was successful, and the patient was admitted to the intensive care unit in stable condition.It was noted that no resistance had been felt when maneuvering the catheters.Both catheters were disposed of by the hospital.Additional information received reported that the physician "botched the procedure" and perforated the heart twice.During the pre-procedure echo at 8:26:59am, a small pericardial effusion was observed.The pre-procedure echo took place after the physician had inserted guide wires and had positioned diagnostic catheters in the heart under fluoroscopy.The patient's family believed that the physician had punctured the heart once prior to ablation.At 9:11am, anesthesiologists told the physician that there was a drop in the patient's blood pressure; the physician continued with ablations until 9:16:54 am.At 9:19:04, the physician noted that he saw a pericardial effusion.The patient "lost 2.5 times his blood" on the table and ended up having "emergency bypass surgery." the patient then experienced kidney failure.The patient was moved out of the intensive care unit "before he was ready" and 14 hours later was transferred back to icu.Five days after the procedure, the patient passed away.Additional information received indicated that there had been no known nuances or concerns going into the procedure that would have been cause for concern.A decapolar diagnostic catheter had been placed in the coronary sinus.The pre-procedure transesophageal echo (tee), which had shown a small pericardial effusion, had been done prior to the transseptal puncture.The transseptal puncture was done under intra-cardiac echo (ice) guidance.Ablation had been taking place in the left atrium near the pulmonary veins; however, it was not reported where the exact perforations were anatomnically.

• 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 DE COSTA RICA S.R.L.; 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: 10194736
• MDR Text Key: 196411192
• Report Number: 2134265-2020-08538
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

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: 06/18/2020
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 81 YR