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

Model Number D134804

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 10/19/2020.The device was visually inspected and it was found that the dome was kinked and electrode #02 was lifted.Then, electrical test was performed and the catheter failed.No electrical readings were observed on electrode #02.Due to the condition of electrode #02, it could be the root cause of the failure in the measurement of the electrical value; however, this cannot be conclusively determined.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint was confirmed.The root cause of the electrode lifted and dome kinked cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.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 patient underwent a left sided atrial flutter (afl) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed an electrode lifted.Initially, it was reported that halfway thru the procedure, while a thermocool® smart touch® sf bi-directional navigation catheter was in use, they lost all electrograms and distal electrodes.The cable was replaced with no resolution.The catheter was replaced and the issue was resolved.At this point, it was noticed that the second distal electrode was damaged.The procedure was continued without further issues.There was no patient consequence reported.It was reported that the carto 3 system was operating per specifications and was not responsible for the product issue.In addition, it was also reported that the catheter was determined to be the root cause of the complaint reported.Follow up was in progress to obtain clarification to this complaint.With the information available at the time, this complaint was assessed as not mdr-reportable.The ecg signal interference was resolved once the ablation catheter was replaced.It is not known if the signal saturation caused the ecg signal to be discernable.It is standard practice to have multiple external systems to monitor the patient¿s ecg rhythm during these procedures.This mitigates the risk that the patient¿s ecg rhythm would be unobservable at any point during the procedure.Therefore, the risk to the patient was low.The electrode damaged issue was assessed as not mdr reportable as there was no indication that the catheter electrode was sharp/lifted.If the catheter electrode was damaged; however, the ring was smooth or dull, then the potential risk that it could cause or contribute to a death or serious injury was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on 10/13/2020 that the dome was kinked and electrode #02 lifted.The biosense webster, inc.Product analysis lab finding of the electrode lifted was assessed as an mdr reportable issue.The awareness date for this finding is 10/13/2020.Additional information was received on 10/21/2020 on the event.The physician stated he saw the electrode was not fully attached to the catheter and that it was tight in the swartz 8fr sl0 sheath upon removal.He believes the electrode damage occurred at this point.The additional information received on 10/21/2020 confirms the lab finding of the reportable electrode issue.The electrode issue remains assessed as mdr reportable.Additional information was received on 11/2/2020 on the event.It was clarified that they lost all intracardiac (ic) signals on the carto 3 system and ep recording system.The physician had the body surface electrocardiograms available to monitor the patient¿s heart rhythm.The signal issue remains assessed as not mdr reportable.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10819707
• MDR Text Key: 249238216
• Report Number: 2029046-2020-01661
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30394486M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• 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