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

Model Number D134702

Device Problem Break (1069)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.During the procedure, the physician noticed that some plastic from the catheter body detached from the proximal electrode and concentrated on the distal electrode.Surgery was not delayed due to the reported event.Procedure was successfully completed.No patient consequences were reported.Sheath information was a smarttouch sf f, 8 french.The physician did not feel any resistance while introducing or retracting the catheter from the sheath.The medical team wasn't able to provide pictures of the plastic material that was found.Broken tip is mdr-reportable.

Manufacturer Narrative

On 2-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.During the procedure, the physician noticed that some plastic from the catheter body detached from the proximal electrode and concentrated on the distal electrode.Surgery was not delayed due to the reported event.Procedure was successfully completed.No patient consequences were reported.Device evaluation details: visual analysis was performed and external damage with foreign material was found on the pebax.The pebax was observed on the microscope and it was found evidence of a rupture.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the issue remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 9-jan-2023, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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: 16043156
• MDR Text Key: 308469837
• Report Number: 2029046-2022-03238
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30892314L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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