MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30457842m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Medical device problem code e2402 (appropriate term / code not available) used to represent "electrocardiogram st segment elevation" manufacturer's ref.#(b)(4).

Event Description

It was reported that a (b)(6) female underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac arrest (coded).Requiring cardiopulmonary resuscitation (cpr), pacing, computed tomography (ct) scan and a temporary pacemaker.After ablation while doing a post-ablation voltage map in the left atrium, the patient went into atrioventricular nodal reentry tachycardia (avnrt) or a junctional type rhythm and their blood pressure dropped.The thermocool® smart touch® sf bi-directional navigation catheter was placed into the left ventricle, and an electrophysiology (ep) study was started.The anesthesiologist then stated that the patient's blood pressure continued to drop lower and they had st segment elevation on the ekg.The intracardiac echo catheter was used to look for a pericardial effusion, there was no effusion, but it was noted that the heart was barely beating.At that time chest compressions were started, and a code was called.The patient stabilized, blood pressure stabilized, and st elevations decreased / resolved.A transthoracic echo (tte) was performed to rule out pericardial effusion and esophageal fistula.Generalized bleeding was also ruled out.The thermocool® smart touch® sf bi-directional navigation catheter and coronary sinus catheter remained in the heart for temporary pacing measures whenever the patient went into the junctional rhythm.The blood pressure would decrease during this rhythm.The patient was being transferred for a ct scan and temporary pacemaker post procedure while still intubated.Physician and staff did not believe that bwi products were not responsible for the patient events.Physician opinion on the cause of this adverse event was probably procedure or patient condition.Adverse event was still unknown after case.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11458226
• MDR Text Key: 241030623
• Report Number: 2029046-2021-00347
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30457842M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR