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

Catalog Number D134722IL

Device Problems Break (1069); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: visual analysis of the returned device revealed reddish material inside and a hole on the pebax on the device, also, a separation on the tip-shaft transition.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Pu (polyurethane) was found applied correctly on tip-shaft transition, proving that the device was manufactured properly.This condition may have been originated during the manipulation of the device during shipping, however, this cannot be conclusively determinated.A manufacturing record evaluation was performed for finished device number 30676541l, and no internal action related to the complaint was found during the review.The evaluation determined that the cause of pebax damage failure cannot be established.However, the blood inside the pebax area found could be related to the reported issue.According to the instructions for use, the following guidelines should be followed: in order to achieve optimal force reading accuracy and stability, allow the catheter to warm up for 2 minutes after connection to the carto¿3 system, prior to use of the force feedback feature.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 reddish material inside accompanied by hole on the pebax.There was also a separation on the tip-shaft transition.The findings were identifed on (b)(6) 2022.During the procedure itself, a force issue occurred.The force value could not be zeroed.A second catheter was used to complete the operation.There was no adverse event reported on patient.Force issue is not mdr-reportable.Hole on the pebax is mdr-reportable.Broken tip is mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER F
• 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: 15179112
• MDR Text Key: 304893670
• Report Number: 2029046-2022-01798
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Catalogue Number: D134722IL
• Device Lot Number: 30676541L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1