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

Model Number D134805

Device Problems Break (1069); High Readings (2459)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial tachycardia left (l-at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip issue occurred.During left atrium mapping, when the catheter and cable were opened, the catheter gives a 'high force' warning.When the catheter was removed, it was observed that the nipple was broken.The catheter was replaced and the problem fixed.Surgery was not delayed due to the reported event.Procedure was successfully completed.No patient consequences.Additional information was received.The damage did not result in wires being exposed.The damage was not detected before or after use on the patient.The damage did not result in any lifted or sharp rings.There was no complication when removal or insertion of the catheter.No pictures available.The force high issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.The nipple broken issue was assessed as mdr reportable for broken tip issue.

Manufacturer Narrative

The event date is unknown.Therefore, the first day of the year has been entered as the event date.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 atrial tachycardia left (l-at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip issue occurred.During left atrium mapping, when the catheter and cable were opened, the catheter gives a 'high force' warning.When the catheter was removed, it was observed that the nipple was broken.The catheter was replaced and the problem fixed.Surgery was not delayed due to the reported event.Procedure was successfully completed.No patient consequences.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 08-mar-2023, there was reddish material found inside the pebax, due to a hole, and the helix bent.Also, foreign material was found below an electrode.The hole on the pebax and the foreign material issues were assessed as mdr reportable.The awareness date for these reportable lab findings was 08-mar-2023.The device evaluation was completed on 08-mar-2023.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual analysis of the returned sample revealed reddish material was found inside pebax, due to a hole, and the helix bent.The damage in the pebax could be related to excessive force.Also, foreign material was found below an electrode.This material was sent to the analytical laboratory to perform a fourier transform infrared analysis (ftir).Infrared results revealed that white particle is primarily composed of a polyethylene - based material with a second component, barium sulfate (baso4).However, source of origin remains unknown.The magnetic sensor functionality was tested on carto, and the device failed.Errors 105 and 106 were observed.The device was dissected on the tip area; loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the device is disconnected.If the problem persists, replace the device cable or the device.A manufacturing record evaluation was performed for the finished device number lot and no internal actions related to the complaint were found during the review.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿tip broken¿ issue and the biosense webster inc.Analysis finding of the "helix bent" issue.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿tip broken¿ issue and the biosense webster inc.Analysis finding of the ¿reddish material and hole found inside pebax" issue.Investigation findings: inappropriate material (c0602)/ investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿foreign material found below an electrode¿ issue.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the biosense webster inc.Analysis finding of the ¿force sensor internally damaged causing error 106¿ 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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 16-feb-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.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: 16229938
• MDR Text Key: 308585948
• Report Number: 2029046-2023-00146
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30787696L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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: UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.