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

Model Number D134805

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504); High Readings (2459)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.(bwi) product analysis lab received the device on 4/15/2021.The device evaluation was completed on 4/30/2021.The device was visually inspected and a reddish material and a hole in the pebax were observed on the catheter.Magnetic sensor functionality was tested on the carto system and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested, and it was working properly, the force values were observed within specifications.The evaluation determined that the cause of the pebax damage cannot be established.The event described force high and icon jumping were unable to be duplicated during the product investigation.However, the blood found inside the pebax area may have contributed to the high force and icon jumping reported.A manufacturing record evaluation was performed for the finished device [30441873m] number, and no internal actions related to the reported complaint condition were identified.As part of bwis quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.Regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.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 an atrial fibrillation (afib) procedure with a thermocool¿ smart touch¿ sf bi-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed a hole in the pebax.Initially, it was reported that when radiofrequency (rf) energy is applied to the catheter, the catheter icon jumped on the carto 3 system and the force values were high.Changing out the catheter cable and the catheter did not resolve the issue.The indifferent electrode was moved from the back to the thigh and the issue was resolved and the procedure continued.No adverse patient consequences were reported.The icon jumping and force high issues were assessed as not mdr reportable.Catheter icon jumping is highly detectable issue.There is no real movement of the catheter.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.The force high issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on 4/30/2021 that there was a reddish material and a hole in the pebax.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 4/30/2021.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11874371
• MDR Text Key: 252328107
• Report Number: 2029046-2021-00797
• 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
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30441873M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER