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

Catalog Number D134721IL

Device Problems Image Orientation Incorrect (1305); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post procedure the bwi product analysis lab identified a cut on the pebax.During the procedure, a force vector issue occurred.The force vector displayed on the carto was not accurate.A second device was used to complete the operation.There was no adverse event reported on patient.The force vector issue is not mdr-reportable.The cut on the pebax is mdr-reportable.

Manufacturer Narrative

The photo analysis and product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, biological material was observed in the pebax of the catheter; however no external damages were observed on the device.This condition could be related to the force vector inverted issue reported by the customer, but force vector could not be observed on the image provided.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 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 31033957l number, and no non-conformance was found during the review.The force issue reported by the customer was 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18031193
• MDR Text Key: 326867675
• Report Number: 2029046-2023-02476
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Catalogue Number: D134721IL
• Device Lot Number: 31033957L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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: ABBOTT AGILIS SHEATH; CARTO 3 SYSTEM