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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926); No Pacing (3268); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered vt and cardiac arrest.During the initial phase of an ischemic vt procedure, the physician inserted an stsf catheter in the patient reaches the heart and right ventricle (rv) with only fluoroscopy as a guide since catheter is still not connected through its cable to the patient interface unit (piu).As soon the catheter was in the right ventricle catheter, manipulation caused premature ventricular contractions (pvcs) and ¿mechanically induce¿ a vt with a cycle length of 310ms ( 194 bpm).The physician therefore wanted to attempt overstimulation of the vt (since the patient is conscious/awake), but as soon as the catheter was connected to the piu all body surface (bs) electrocardiographic (ecg) signals disappears from carto and ep recording system and carto displayed the error ¿current leakage¿.Pacing through ablation catheter was not possible.Detaching the stsf cable from the piu restored the bs ecg signal and the ¿current leakage¿ error message disappeared.Patient was still in a 300ms vt.Changing the cable could not solve the issue.The patient remained conscious but became hemodynamically instable, so the physician decided to unpack and use a viking catheter (2 poles catheter from boston scientific) for pacing while a new stsf is been collected from the material store room.Since it seemed impossible to pace over the stsf connected through carto, the physician decides to use direct stimulation by connecting the viking catheter to the biotronik reocor device.Overstimulation of the vt was still not possible with the reocor device and patient lost consciousness and was not hemodynamically stable anymore.Therefore the focus was re-directed to an electrical cardioversion (and attempts at preventing overstimulation of the vt).The ecv (electrical cardioversion) is not successful and patient then seemed to have a fast vt/vf (important: people present at this time do not realize that after ecv the viking catheter in rv is still pacing at 200 ppm).The rea alarm was called and reanimation maneuvers were being performed by hospital staff and anesthesia team arrives to assist the reanimation.During the reanimation maneuvers the pacing spike from the viking positioned in rv was noticed and stopped.The next ecv was then successful and implantable cardioverter-defibrillator (icd) from patient took over and dictated the heart rhythm.Patient then became hemodynamically stable and after discussion among physicians, the carto vt procedure is then resumed.Attaching the new stsf to the piu using a new cable solves the current leakage issue.The procedure was then completed without any further clinical complication.Consequence for the patient: possible neurological damage and possible broken ribs (further details will follow).To be noted, at the end of the procedure the patient was successfully woken up.Concerning the initial clinical complication: time from start initial vt to the successful ecv is 7min 23s.Current leakage is not mdr-reportable.Bad/partial ecg is not mdr-reportable.The pacing issue is mdr-reportable.Since the event is life threatening and may require intervention prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 3-mar-2022, bwi received additional information regarding the event.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was bwi product malfunction and procedure.The patient outcome was fully recovered (no residual effects) and improved.During the signal loss issue the affected catheter was inside the patient¿s body pacing.The pacing lead are connected to the carto® 3 piu primary pacing port.No ablation points were made with the defective catheter.The pacing stimulator being used during the procedure was biotronik.The pacing was emergency pacing and furthermore the emergency pacing was also performed by direct pacing using a biotronik reocor device.After post-procedure analysis determined that the reocor device was pacing during the whole ecv/reanimation process and not allowing a successful ecv.The generator does not require maintenance.Changing the cable of the catheter did not solve the issues/error.Visitag was not used with defective catheter.There was no evidence of a cerebrovascular accident or neurological lesion.There was no evidence of char or blood thrombus / clot during the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

On 15-jun-2022, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30661653l 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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER.
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; 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: 13519506
• MDR Text Key: 289174870
• Report Number: 2029046-2022-00280
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30661653L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2021
• 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
• Treatment: BIOTRONIK REOCOR DEVICE.; CARTO 3 SYSTEM.; EP RECORDING SYSTEM.; VIKING CATHETER.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male