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

Model Number D134805

Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.(bwi) product analysis lab received the device on 08-oct-2021.The device evaluation was completed on 9-nov-2021.Bwi conducted a visual inspection and force evaluation of the returned device.Visual analysis of the returned sample revealed that reddish material was observed in the pebax, a hole was found on the thermocool® smart touch® sf bi-directional navigation catheter.Magnetic sensor functionality was tested on carto, and the catheter failed; errors 105 and 106 were observed.A failure analysis was performed, and the catheter 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 evaluation determined that the cause of pebax damage failure cannot be established.The event described reduced force accuracy was unable to be duplicated during the product investigation.However, the blood found inside the pebax area may have contributed to the high force reported.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.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 patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the biosense webster inc, (bwi) product analysis lab observed a reddish material and a hole in the pebax.Initially, it was reported that the carto 3 system would lose force when going on radiofrequency (rf) with the thermocool stsf catheter.In addition, the carto 3 system displayed "reduced force accuracy" error 87 and error 85 (error message unknown by the caller).The thermocool stsf catheter was re-zeroed without resolution.The cable was replaced without resolution.The thermocool stsf catheter was replaced, and the issue was resolved.The procedure continued successfully.The carto 3 system is operating per specs and is not responsible for the product issue.No adverse patient consequences were reported.The force issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.The issue with no force value displayed was assessed as not mdr reportable.The procedure can be completed without relying on the force data.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that there was a reddish material and a hole on the pebax.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2021.

• 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: 12929816
• MDR Text Key: 287351768
• Report Number: 2029046-2021-02099
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30598198L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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: UNKNOWN BRAND CABLE.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.; UNK_CARTO 3.