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

Model Number D134804

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Since this device could not be traced to a specific event, date of event has been left blank as this is unknown.The device evaluation was completed.Visual analysis of the returned catheter revealed reddish material inside and a cut in the pebax.Carto test was performed, in accordance with biosense webster, inc.S (bwi) procedures.The returned sample was connected to the carto3 system and the force error was observed.Therefore, the catheter was dissected on the tip area.Loss of electrical continuity of the green paired wires to sensor was found, concluding that this is an internal failure of the sensor.A manufacturing record evaluation was performed for the finished device 30423230m number, and no internal action related to the complaint was found during the review.As part of bwis quality process, all devices are manufactured, inspected, and released to approved specifications.The evaluation determined that the cause of pebax damage failure cannot be established.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 catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.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

On 3/16/2021, biosense webster, inc.S (bwi) product analysis lab received a thermocool¿ smart touch¿ sf bi-directional navigation catheter which was unable to be matched to any existing customer complaint file.Multiple attempts have been made to obtain clarification for the product received, however, no further information has been made available.As such, this complaint has been opened to document the investigation details.On 5/18/2021, visual analysis of the returned sample revealed a reddish material inside and a cut in the pebax.These findings were reviewed and determined that the issue is a mdr reportable malfunction since the integrity of the device is compromised.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12010454
• MDR Text Key: 261985874
• Report Number: 2029046-2021-00939
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30423230M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• 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