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

Model Number D134805

Device Problem Signal Artifact/Noise (1036)

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

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

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 30433322m number, and no internal action related to the complaint was found during the review.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).

Event Description

It was reported that a patient underwent an isvt cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where debilitating noise on all signals occurred.It was reported that there was noise saturated on all the ekg signals, on the carto 3 and recording system.The catheter cable was disconnected and reconnected, without resolution.The cable was replaced without resolution.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue was resolved.The carto 3 system is operating per specs and is not responsible for the product issue.The catheter has been determined to be the root cause of the complaint reported.The procedure was continued.Additionally, the soundstar eco cable was not properly connecting into the port on the piu.The connector on the eco cable was not "clicking" into place, and the connection was very loose.Caller noted that there appears to be a chip on the lip of the connector for the eco cable.The eco cable was replaced, and the issue was resolved.The procedure continued.On 11/12/20 it was confirmed that all signals were affected and that the physician did not have any external ecg channels to monitor the patient during the interference.The thermocool® smart touch® sf bi-directional navigation catheter was inside the patient¿s body during the event.The loose connection is not mdr-reportable.The debilitating noise on all signals is an mdr-reportable event.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 10986738
• MDR Text Key: 247900417
• Report Number: 2029046-2020-01913
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30433322M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1