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

Catalog Number D134805

Device Problems Image Orientation Incorrect (1305); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a cut on the pebax and internal parts exposed.The thermocool® smart touch® sf bi-directional navigation catheter was used in the procedure.The patient interface unit (piu) was connected and 0 was obtained.Immediately after the first ablation, the vector turned 180 degrees in the opposite direction from the original and contact force (cf) rose sharply.Feeling discomfort, the ablation was stopped after about 3 seconds.When thermocool® smart touch® sf bi-directional navigation catheter was removed from the intracardiac cavity and checked, it was confirmed that blood was flowing into the spring portion of the catheter tip.The problem was resolved by replacing the thermocool® smart touch® sf bi-directional navigation catheter to another new one.There was no effect on the patient.The procedure was completed without patient's consequence.Additional information was received.The agilis 8.5fr sheath was used.No difficulty experienced while maneuvering the catheter or during the withdrawal.Clarified that it was the physician that felt the discomfort, the ablation was stopped after about 3 seconds.Not the patient.No patient symptoms.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 30-oct-2023 there was a cut on the pebax with reddish-brown material inside and internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a cut on the pebax and internal parts exposed on 30-oct-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The investigation was completed on 30-oct-2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a cut on the 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; however, this could not be conclusively determined.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: pc-(b)(4).

• 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: 18213654
• MDR Text Key: 330123650
• Report Number: 2029046-2023-02763
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31056186L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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
• Treatment: AGILIS 8.5FR SHEATH; UNK_CARTO 3