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

Catalog Number D134721IL

Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/15/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) and the biosense webster inc, (bwi) product analysis lab observed a hole on the pebax.Initially, it was reported that during the procedure, the force value could not be zeroed.A second catheter was used to complete the operation.No adverse patient consequences were reported.The force issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and a reddish material was observed in the pebax and a hole was found.The hole on the pebax was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2021.

Manufacturer Narrative

(b)(6).The catheter was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and spi screening test of the returned catheter.Visual analysis of the returned catheter revealed reddish material inside and a hole on the pebax of the stsf catheter.Spi screening test was performed, in accordance with bwi procedures.The returned sample was connected to the carto3 system and the force values were observed within specifications.The evaluation determined that the cause of the pebax damage failure cannot be established.The event described regarding the force issue was unable to be duplicated during the product investigation.However, the blood inside the pebax area found could be related to the reported issue.A manufacturing record evaluation was performed for the finished device 30564155l 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.To minimize force issues, the following guidelines should be followed.In order to achieve optimal force reading accuracy and stability, allow the catheter to warm up for 2 minutes after connection to the carto¿3 system, prior to use of the force feedback feature.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12947222
• MDR Text Key: 286119194
• Report Number: 2029046-2021-02119
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

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: 06/03/2022
• Device Catalogue Number: D134721IL
• Device Lot Number: 30564155L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER