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

Model Number D134804

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504); Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the handle was two toned; one side was light blue, and the other side was darker blue.This occurrence was investigated, and the root cause was determined to be a difference of the blue color for the raw materials that were used by the supplier to manufacture the catheter handles.The photo does not provided sufficient information related to the force, magnetic sensor and noise issues reported by the customer and therefore no results can be obtained from it.The product was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection and functional test of the returned device.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 also, the catheter was observed with a bicolor condition.Then the electrical was tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The handle bicolor is considered to be a cosmetic issue and does not have any impact on the catheter functionality or pose any risk to the patient.We are working with our suppliers to remediate this occurrence.The issues reported by the customer as handle bicolor was confirmed.However, the evaluation determined that the cause of pebax damage failure cannot be established.The foreign material inside the pebax could be related to the issues of noise and force reported by the customer.A manufacturing record evaluation was performed for the finished device 30957791l number, and no internal action was found during the review.The instructions for use (ifu) contain the following warning stated in the carto 3 system manual, which was performed for this product: the force sensor error of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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 a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and after the procedure the bwi product analysis lab a cut on the pebax with internal parts exposed.During the procedure, several issues were identified as the catheter was reportedly "spazzing out" during ablation.The force values were lost and the catheter appeared to be jumping out of the fam (fast anatomical mapping) and matrix that had been created.The ablation signals were extremely noisy on both carto® 3 and recording systems and were visually insufficient.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.This failed catheter had two different shades of blue on the handle.The case continued.No patient consequences were reported.Hole in the pebax/internal parts exposed is mdr-reportable.Force issue is not mdr-reportable.Bad/partial ecg is not mdr-reportable.Icon jumping is not mdr-reportable.Cosmetic damage is not mdr-reportable.

• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17262442
• MDR Text Key: 318686273
• Report Number: 2029046-2023-01445
• Device Sequence Number: 1
• Product Code: LPB
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30957791L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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