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

Model Number D134805

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

Patient Problems Vasoconstriction (2126); No Code Available (3191)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6)."no code available" is being used to represent the surgical intervention.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient ((b)(6), underwent cardiac ablation procedure for premature ventricular contraction (pvc)) with thermocool® smart touch® sf bi-directional navigation catheter and suffered coronary artery spasm requiring surgical intervention.It was reported that during a follow up ablation near the left coronary cusp (believed to be 1cm away), where the pvc was originating, the patient moved.Two more short ablations were performed and on the last one a slow impedance rise was noticed.At this point the patient's blood pressure was checked and pulseless electrical activity (pea) was diagnosed.The physician called a code blue on the patient and chest compressions were administered.A cardiac catheterization revealed left main coronary artery spasms.A left ventricular assist device (lvad) was implanted as well as a coronary stent in the left main and left circumflex arteries.The patient regained a pulse and was kept under anesthesia and transported to the intensive care unit (icu) for observation.The patient ¿s condition has since improved and the patient is moving their extremities, but as of (b)(6) 2020 they were still hospitalized.The physician did not believe that biosense webster products contributed to the patient event and considers patient¿s condition as the cause of the event as the patient coughed during ablation.The impedance cut-off was exceeded, and the system stopped the ablation.The generator power was set to 35w.A stryker-reprocessed soundstar catheter was also in use.The event is conservatively reported under the ablation catheter.The user-defined impedance cut-off is not an mdr-reportable issue.However, since coronary artery spasm may be life threatening it is mdr reportable.

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10852566
• MDR Text Key: 217372502
• Report Number: 2029046-2020-01735
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 47 YR