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

Model Number D134801

Device Problems Complete Blockage (1094); Patient Device Interaction Problem (4001)

Patient Problem Respiratory Failure (2484)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 30518148m 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 an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered respiratory distress post procedure.The stsf catheter when outside the patient¿s body flushed, clogging of tip irrigation hole.The issue was resolved by changing the smart touch sf catheter to another one.The lasso had noise (on both the carto3 and the lab).This occurred when the catheter was placed to the pv.The cable was changed and then the lasso 2515 nav eco catheter was changed.The procedure was completed without patient's consequence.Spo decreased to 26.0% during the treatment, and the size of the eye gel was changed or replaced as needed.After that, pacing was discontinued, and hr decreased to about 40 under sr and spo decreased to 26.0%.Although the patient was intubated and placed under respiratory management, spo2 remained low, and it was transferred to the icu.Worsening of respiratory status.The physician commented that i think it is not because of ablation but because of respiratory management.However, it is unknown at this point what was the problem with respiratory management.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

On 11-aug-2021, bwi received additional information regarding the event.There were no error report about the pump.The issue was resolved by replacing the cable and catheter.The signal interference (noise) observed on carto® and recording system.Bs ecg at polygraph was available.The affected catheter was inside the patient¿s body during the signal interference.Additional information received 27-aug-2021: this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure.The event is related to respiratory management.Intervention provided: respiratory management.Patient outcome of the adverse event: unchanged.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
• MDR Report Key: 12292367
• MDR Text Key: 265553791
• Report Number: 2029046-2021-01304
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30518148M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening