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

Model Number D134805

Device Problems Entrapment of Device (1212); Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

It was reported that a 30-year-old female patient (233lbs, 5.6 ft) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The deflection was stuck and the case was cancelled after several issues.The patient suffered a complication during the case.There was a possible arterial dissection.The physician was going retrograde aortic through the right femoral artery access.When the doctor was in the aorta the deflected the smart touch surround flow df curve catheter and could not "undeflect" it.The physician indicated the catheter was stuck in that deflected position.He moved it around in the aorta and eventually got it to straighten out.He removed it and the abbott short sheath they were using and examined it for damage once outside the body.The physician noted there didn't seem to be damage to the catheter but there was a kink in the sheath that the physician indicated might have caused damage while moving it through the artery.Upon removing the sheath the patient's blood pressure dropped from 110/70, to 90/60.The patient was "screaming and hollering in pain for most of the procedure." when the blood pressure dropped they checked for an effusion with the soundstar catheter using an intracardiac echocardiogram, and found none.They also injected contrast to check for arterial dissection with fluoro and found none.The patient was allergic to heparin and they used angiomax which he noted cannot be reversed.They applied manual pressure for 15 minutes and then used "fem stop" for 15 minutes and then the blood pressure came back up to normal.The procedure was abandoned.The patient was not having enough pvcs to finish anyway.The patient was admitted for overnight observation.This was not a case study.The physician indicated that another possible cause was when moving the abbott short sheath through the groin, it may have "dilated the incision" causing external bleeding through the groin.This may have happened because the patient was moving around a lot during the procedure.The adverse event was noticed after using the biosense webster product.As previously mentioned, the kink in the short sheath and the initial inability to deflect the catheter caused the physician to grow concerned.Once he removed the sheath and catheter (that he was able to un-deflect after advancing and retracting in the aorta), the drop in blood pressure was noticed.The physician believes that the patient condition of moving during the procedure caused the short sheath to dilate the access site, causing the slight drop in blood pressure.A femstop was used to hold pressure on the access site for 15 minutes, then manual pressure was held for another 15 minutes to ensure that the bleeding had stopped.Contrast and fluoro and doppler ultrasound on the patient¿s ankle were used to ensure that the patient had a strong pulse and that there was no dissection.No patient complication was ever discovered.The patient made a full recovery and had only complained of pain in the groin site due to a hematoma.The patient was just help overnight to monitor the situation.She was allowed to go home when it was determined that she was fully healed.Fluoro, contrast and doppler ultrasound were used to confirm that there was no dissection.The generator used was a bwi smartablate generator.The patient was under local anesthesia for about an hour.No transseptal puncture was performed during the case.The cancellation of the procedure was due to a lack of pvcs and not due to a death or serious injury.The patient was just help overnight to monitor the situation.She was allowed to go home when it was determined that she was fully healed.No extended stay was required.The damage didn¿t result in wires being exposed or any lifted or sharp rings.No resistance or difficulty during insertion or removal was observed.There doesn¿t appear to be any sort of noticeable structural damage to the catheter and the catheter was not pre-shaped.The sheath was a 8.5fr abbott fast-cath short sheath.The bleeding was related to the abbott sheath.Stuck deflection is not mdr-reportable.Medical device entrapment is mdr-reportable.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 21-jul-2022, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a 30-year-old female patient (233lbs, 5.6 ft) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The deflection was stuck and the case was cancelled after several issues.Device evaluation details: visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.An electrical test was performed, and no electrical issues were found.Od test was performed and measurements are within specifications.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14988010
• MDR Text Key: 303919848
• Report Number: 2029046-2022-01580
• 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,Followup
• Report Date: 08/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30781372L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2022
• 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: ABBOTT SHORT SHEATH; SOUNDSTAR CATHETER
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 106 KG