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

Catalog Number D134804

Device Problems Break (1069); Complete Blockage (1094); Entrapment of Device (1212)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment issue and a tear noted below the porous tip of the catheter issue occurred.The ablation catheter was stuck in the left ventricle.The catheter appeared straight under fluoroscopy imaging, on the carto map, and via intracardiac echocardiography (ice) imaging.The physician thought that the catheter was caught in the head of the chordae tendineae/anterior papillary muscle.The physician could not release the catheter until advancing the vizigo sheath as far as possible and forcefully pulling/retracting the catheter back into the sheath.When the catheter was removed from the body, a tear was noted below the porous tip of the catheter, near the force spring.It is unclear whether this occurred before, during, or after the entanglement.This was noticed when attempting to flush the catheter post removal- the catheter was not irrigating.The catheter was replaced to continue.No patient injury.Additional information was received.There was difficulty experienced while maneuvering the catheter or during the withdrawal.The physician stated ¿forcefully¿.It was unknown if the catheter pebax was physically damaged.A picture is not available.Physician stated that it appeared to be torn at the tip.No error noted from the irrigation pump.Correct catheter settings were selected.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No irrigation issues were noted.The irrigating issue was assessed as non reportable.Occlusion or no irrigation is highly detectable by the physician.The most likely consequence was an intraprocedural delay the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The medical device entrapment issue and a tear noted below the porous tip of the catheter were assessed as mdr reportable issues.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 09-aug-2023.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The ablation catheter was stuck in the left ventricle.The catheter appeared straight under fluoroscopy imaging, on the carto map, and via intracardiac echocardiography (ice) imaging.The physician thought that the catheter was caught in the head of the chordae tendineae/anterior papillary muscle.The physician could not release the catheter until advancing the vizigo sheath as far as possible and forcefully pulling/retracting the catheter back into the sheath.When the catheter was removed from the body, a tear was noted below the porous tip of the catheter, near the force spring.It is unclear whether this occurred before, during, or after the entanglement.This was noticed when attempting to flush the catheter post removal- the catheter was not irrigating.The catheter was replaced to continue.No patient injury.The device evaluation was completed on 23-aug-2023.Visual inspection, microscopic examination, outer diameter (od), deflection, and patency test of the returned device were performed following bwi procedures.Visual analysis revealed that there was a reddish material and a cut on the pebax surface leaving internal parts exposed.The damage observed could be related to the manipulation of the device during the procedure; however, this can not be conclusively determined.A patency test was performed, and the device was not flushing correctly, then the dome was microscopically inspected, and it was found occluded with dry reddish material.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.Outer diameter 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 entrapment 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.In the other hand, occlusion and broken tip issue reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿medical device entrapment¿.-investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿tear noted below the porous tip of the catheter¿ and the biosense webster inc.Analysis finding of the ¿cut on the pebax surface leaving internal parts exposed¿.-investigation findings: operational problem identified (c13)/ investigation conclusions cause not established (d15) / component code: dome (g04046) were selected as related to the customer¿s reported ¿irrigating¿ issue.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17501229
• MDR Text Key: 320809966
• Report Number: 2029046-2023-01751
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 30880872L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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: UNK BRAND PUMP.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.