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

Catalog Number D134721IL

Device Problems Insufficient Cooling (1130); Material Puncture/Hole (1504)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a cut on pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue.Then the device was tested, the generator test was performed the temperature and impedance test was verified, and the device was found working correctly.No temperature or impedance issues were observed, for flow the catheter was irrigated correctly, and no liquid leakage was detected during the analysis.A manufacturing record evaluation was performed for the finished device 30697920l number, and no internal actions related to the complaint were found during the review.The customer complaint regarding the temperature issue was unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The (ifu) instructions for use contain the following recommendations: if temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.The irrigation system must be rechecked before restarting rf delivery.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

A patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab identified a cut on pebax with reddish-brown material inside and internal parts exposed.The finding was identified on (b)(6) 2022.It was initially reported that during the procedure, the temperature displayed changed a lot in one moment.The second catheter was used to complete the operation.There was no report on patient injury.Temperature issue is not mdr-reportable.Cut/hole in the pebax is mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15602901
• MDR Text Key: 307269863
• Report Number: 2029046-2022-02522
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2023
• Device Catalogue Number: D134721IL
• Device Lot Number: 30697920L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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