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

Model Number D134805

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

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: the reported year is 2021.The device evaluation was completed on (b)(6) 2021.The visual analysis of the returned sample revealed that the thermocool® smart touch® sf bi-directional navigation catheter was received with reddish material inside the pebax, a microscopic inspection revealed that the pebax has a hole on it.During the generator test, it was noted that the generator functionality failed due to intermittence.A failure analysis was performed, and it was found that there was a loss of electrical resistance from the cut to the tip creating the temperature issue.A manufacturing record evaluation was performed for the finished device with lot number 30505990l, and no internal actions related to the reported complaint condition were identified.As part of the biosense webster quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The failure of the catheter is related to a temperature issue, for this failure mode, the instructions for use contain the following warnings and precautions: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.If temperature still is not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.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 persistent atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a hole on the pebax and found reddish material in it.Initially, it was reported that at the beginning of the procedure, there was an absence of temperature information as soon as the catheter was connected.The cable was replaced but the issue did not resolve.When the catheter was replaced, the issue resolved.There was no patient consequence.The 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.This event is being reported because the biosense webster, inc.Product analysis lab received the device for evaluation and found on (b)(6) 2021 that there was a hole on the pebax and reddish material inside of it.The foreign material inside the pebax - external damage was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 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: 12331918
• MDR Text Key: 266952349
• Report Number: 2029046-2021-01353
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2021

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: 02/12/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30505990L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2021
• 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