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

Model Number D132705

Device Problem Device Sensing Problem (2917)

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

Event Date 07/23/2021

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax with reddish-brown material inside and internal parts exposed.The finding was identified on (b)(6) 2021.It was reported by the caller there was a temperature sensor error (number unknown) was displayed on the carto 3 system when the catheter was connected to the front of the patient interface unit.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved.The procedure was completed with patient consequence.The caller is requesting a replacement catheter.Temperature issue is not mdr-reportable.Hole in the pebax and exposed internal parts is mdr-reportable.

Manufacturer Narrative

Device evaluation details: the catheter was returned to biosense webster for evaluation.Bwi conducted visual inspection and generator testing of the returned device.Visual analysis of the returned catheter revealed reddish material inside and a hole on the pebax of the thmcl smrttch catheter.Generator testing was performed, in accordance with bwi procedures.No temperature readings were observed.Therefore, per this condition it can be determined that there is a loss of thermocouple circuit inside the tip.A manufacturing record evaluation was performed for the finished device 30551020m number, and no internal action related to the complaint was found during the review.The instructions for use contain the following recommendations: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.If temperature still is not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.The described event related to the temperature problem was confirmed and, in addition, the blood inside the pebax could be also related to the reported issue however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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
• MDR Report Key: 12670746
• MDR Text Key: 284288001
• Report Number: 2029046-2021-01798
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30551020M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1