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

Model Number D134805

Device Problem Mechanical Jam (2983)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 bi-directional navigation catheter.The catheter had an issue with deflection.It was reported that during approach to lv from the ascending aorta, the curve of the catheter was maximized, and when the catheter was turned from a j to a u shape and trying to enter the lv at the back of the catheter, the bending became stronger, and torque was transmitted.They went further from the u shape and made a single rotation like the type.This occurred during lv entry.How to complete the procedure: in order to prevent the ring from becoming like a knot tied from, apply torque at the same time while slowly pulling the ring back to the straight ring shape and then release it safely.The catheter was replaced because some irregularity had developed on the catheter, and the procedure was completed safely.Clinical course: none the procedure was completed without patient's consequence.The physician commented that request information to request information if there was any information although there was no effect on patients.Decision based on current information provided, it appears that this was a deflection issue but upon receipt of additional information complaint will be reevaluated.On 25-nov-2021, bwi received additional information indicating the following: there was difficulty in removing the catheter, they had to remove the catheter carefully not to make a knot.No ring, electrode or other physical damage observed at the distal end of the catheter; however, it seems to one full turned like making by the shaft.Given additional information provided this complaint will become reportable.Deflection stuck is mdr-reportable.

Manufacturer Narrative

On 13-dec-2021, bwi received additional information regarding the event.The curve of the catheter was stuck/jammed in a full deflected position.The knob/piston was not unable to be turned and/or pushed up and down.They had difficulty removing the catheter, they had to remove it carefully as to not to make a knot.There was no ring, electrode or other physical damage observed at the distal end of the catheter, however it seems that one full turned like making ¿¿¿ by the shaft.The brand, model/catalog and french size of the sheath used was swarts 8.5.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 6-jan-2022, 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).

Manufacturer Narrative

On 11-feb-2022, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The catheter had an issue with deflection.It was reported that during approach to lv from the ascending aorta, the curve of the catheter was maximized, and when the catheter was turned from a j to a u shape and trying to enter the lv at the back of the catheter, the bending became stronger, and torque was transmitted.They went further from the u shape and made a single rotation like the ¿ type.This occurred during lv entry.How to complete the procedure: in order to prevent the ring from becoming like a knot tied from ¿, apply torque at the same time while slowly pulling the ring back to the straight ring shape and then release it safely.The catheter was replaced because some irregularity had developed on the catheter, and the procedure was completed safely.Clinical course: none the procedure was completed without patient's consequence.The physician commented that request information to request information if there was any information although there was no effect on patients.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the smart touch bidirectional sf.Deflection testing was performed by bwi procedures.The catheter was working correctly, and no deflection issues were detected during the analysis.A manufacturing record evaluation was performed for the finished device 30609913l number, and no internal actions related to the complaint were found during the review.The event described could not be confirmed as the device performed without any deflection issues.Although no product defect was identified, 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).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12932174
• MDR Text Key: 287352476
• Report Number: 2029046-2021-02115
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1