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

Model Number D132705

Device Problem Signal Artifact/Noise (1036)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

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 ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and there was a no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.Initially it was reported that the connection of the thermocool® smart touch¿ bi-directional navigation catheter induced important artifact on all other signals (intracardiac and ecg), as well as on the anesthetist ecg.Disconnecting the catheter resolves the issue.There was no patient consequence reported.Multiple attempts had been made to obtain clarification to this complaint.However, no further information had been made available.With the information available, this event was assessed as not mdr reportable for a ¿bad/partial ecg (body surface and/or intracardiac)¿ issue as the risk to the patient was low.Additional information was received on 19-may-2022.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was not inside the patient¿s body.There was no patient impact.Additional follow-up was made to confirm whether signal interference (noise/loss) was not observed on carto® and the recording system.The file will be re-reviewed if additional information is received at a later date.However, with the additional response stating that there was a no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm, the signal issue was reassessed to mdr reportable.Therefore, the awareness date for this mdr reportable issue is 19-may-2022.

Manufacturer Narrative

In the 3500a initial report it was reported that additional follow-up was made to confirm whether signal interference (noise/loss) was not observed on carto® and the recording system.A response was received on 21-jul-2022 stating that it was unknown about the noise.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 investigation was completed on 07-sep-2022.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30629971m and no internal actions related to the complaint was found during the review.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¿ 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14705570
• MDR Text Key: 296181423
• Report Number: 2029046-2022-01306
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30629971M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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 ANESTHESIA MONITOR; UNKNOWN BRAND DEFIBRILLATOR; UNKNOWN BRAND RECORDING SYSTEM; UNK_CARTO 3