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); High Readings (2459)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.Product analysis lab received the device on 07-jun-2022.The device evaluation was completed on (b)(6) 2022.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material was observed on the pebax, and a hole was found.A magnetic sensor functionality test was performed, and the device was recognized on the system; however, error 105 was displayed on the screen due to an open circuit on the tip area.The evaluation determined that the cause of pebax damage failure cannot be established.The event described as a force high could be related to the blood found inside the pebax.A manufacturing record evaluation was performed for the finished device [30731728l] number, and no internal actions related to the reported complaint condition were identified.The force high reported by the customer was confirmed per the blood found inside the pebax.Additionally, an open circuit on the tip was found to cause a magnetic sensor error.The instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.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.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.

Event Description

It was reported that a patient underwent a paroxysmal supraventricular tachycardia procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed a hole on the pebax.Initially, it was reported that right after ablation was started, the contact force (cf) was high.There was no error code displayed.The cable was replaced and the issue did not resolve.When the catheter was exchanged with another catheter, the issue resolved.The procedure was completed without patient consequence.The force high issue was assessed as not mdr reportable.The 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 visual analysis revealed reddish material was found on the pebax, and a hole was observed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2022.

• 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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15332222
• MDR Text Key: 305505593
• Report Number: 2029046-2022-02060
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30731728L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2022
• 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: UNK BRAND CABLE; UNK BRAND CATHETER