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

Model Number D134805

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30604873l number, and no internal action related to the complaint was found during the review.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 a female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The catheter was wrapped about papillary muscles and was caught.The physician could not remove the catheter manually.Surgical intervention was required.During an idvt procedure, a foley catheter insertion was needed.While manipulating the patient, the ablation catheter wrapped about papillary muscles and was caught.The physician could not remove the catheter manually.The patient was being prepped for surgery at the time of the call.The catheter was not deflected and the knob was able to be turned.It is unknown if there was ring, electrode or other physical damage observed at the distal end of the catheter.The physician¿s opinion on the cause of this adverse event: procedure.Patient outcome of the adverse event: fully recovered (no residual effects).The patient was taken to the or for surgery.It was not reported how long the patient stayed following.Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 30-nov-2021, the product investigation was completed.It was reported that a female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The catheter was wrapped about papillary muscles and was caught.The physician could not remove the catheter manually.Surgical intervention was required.During an idvt procedure, a foley catheter insertion was needed.While manipulating the patient, the ablation catheter wrapped about papillary muscles and was caught.The physician could not remove the catheter manually.The patient was being prepped for surgery at the time of the call.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch bidirectional sf catheter.Per the event, several tests were performed.The magnetic features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.The catheter passed the od test of pu margin.During the test, no impedance readings were observed on electrode #01.However, the temperature was displayed normally.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.A manufacturing record evaluation was performed for the finished device 30604873l number, and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the catheter 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 4-nov-2021, 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 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: 12687188
• MDR Text Key: 278098890
• Report Number: 2029046-2021-01818
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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: SMARTABLATE GENERATOR; SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female