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

Model Number D134805

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

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

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned for evaluation and the evaluation has been completed the returned device's visual inspection and screening tests were performed following biosense webster (bwi) procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.Additionally, according to pictures provided by the customer, reddish material (presumably blood) was observed inside the pebax; however, no external damages were observed on the device.The photo does not provided sufficient information related to the force issue reported by the customer, and therefore no results can be obtained from the picture.The force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No malfunction was observed.The events described were unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with the tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.A manufacturing record evaluation was performed for the finished device, and no non-conformances related to the complaint were found during the review.Biosense webster¿s quality process ensures 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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported that the carto 3 system was displaying inaccurate force readings.Caller stated the physician stated the force vector felt "sticky" meaning it lingered longer than it should have when force was removed from a structure.Caller stated that upon inspection of the catheter, a pool of blood was found inside the "clear area" at the tip of the catheter.There was no report of physical damage.No troubleshooting was done during the procedure.Caller stated they continued using the catheter with having to rezero several times throughout the case.There was no patient consequence.On 3-jul-2023, the bwi pal revealed that a visual inspection of the returned device found a hole on the pebax with internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 3-jul-2023 and reassessed it as mdr reportable.The customer¿s reported force issues are not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.

• 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: 17358449
• MDR Text Key: 320291697
• Report Number: 2029046-2023-01545
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31029993L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM