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

Model Number D134805

Device Problems Material Puncture/Hole (1504); High Readings (2459); Temperature Problem (3022)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 10-sep-2021.Visual analysis of the returned sample revealed that reddish material was observed in the pebax and a hole was found on the thermocool® smart touch® sf uni-directional navigation catheter.Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested, and it was working properly as the force values were observed within specifications.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.The evaluation determined that the cause of pebax damage failure cannot be established.The event described force high and temperature issue were unable to be duplicated during the product investigation.However, the reddish material found inside the pebax area may have contributed to the high force and temperature issue reported.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action was found during the review.As part of bwi¿s 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.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.If the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.If temperature is still not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.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 uni-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole on the pebax.Initially, it was reported that the smartablate generator was not displaying a temperature during the procedure intermittently after some ablation had been completed.The force values were also noticed to be rising during ablation.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved, and the procedure was continued.The smartablate generator is operating per specs and is not responsible for the product issue.The no temperature issue was assessed as not mdr reportable.The ablation cannot be performed since there is no rf energy applied.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The high force issue was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.This event is being reported because the biosense webster, inc.Product analysis lab received the device for evaluation and found that there was a hole on the pebax and reddish material inside of it.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding is (b)(6) 2021.

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-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: 12544777
• MDR Text Key: 273844893
• Report Number: 2029046-2021-01606
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30547330M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• 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: UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNK_SMARTABLATE GENERATOR