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

Model Number D134702

Device Problems Delivered as Unsterile Product (1421); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559)

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

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a sterilization compromised issue occurred.It was reported by the biosense webster inc.(bwi) representative that there was a visual ¿kink¿ (lot 31029876l).The kink was noted after the catheter was removed from the sterile packaging.The electrophysiology (ep) lab staff brought to the attention of the bwi representative that the catheter was not in the protective clear tube within the sterile packaging prior to removal.It was reported that the ¿kink¿ was not the result of an engaged deflection mechanism.The catheter was replaced, and the issue was resolved.The case continued.It was also reported that a catheter force sensor error (error#106) was displayed on the carto® 3 system.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved.The case continued.It was also reported that the third thermocool smarttouch® sf catheter had the reduced force accuracy displayed when radio frequency was delivered.The physician did not want to continue the use of the catheter.The cable was replaced, but the issue continued.The catheter was replaced, and the issue was resolved.The case continued.No adverse patient consequence was reported.The force issue is 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.The force sensor error (106) is not mdr reportable.The warning functioned as intended.The sterilization compromised issue is mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a sterilization compromised issue occurred.It was reported by the biosense webster inc.(bwi) representative that there was a visual ¿kink¿ (lot 31029876l).The kink was noted after the catheter was removed from the sterile packaging.The electrophysiology (ep) lab staff brought to the attention of the bwi representative that the catheter was not in the protective clear tube within the sterile packaging prior to removal.It was reported that the ¿kink¿ was not the result of an engaged deflection mechanism.The catheter was replaced, and the issue was resolved.The case continued.It was also reported that a catheter force sensor error (error#106) was displayed on the carto® 3 system.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved.The case continued.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The sterilization package was not returned for analysis.The device was connected to carto 3 system and the device was recognized and visualized; however, error 106 appeared due to an open circuit on the tip area.A manufacturing record evaluation was performed for the finished device number lot 31029876l and no internal action related to the complaint was found during the review.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: 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.If the force problem persists, replace the catheter cable or the catheter.On the other hand, the package was not returned for analysis.Due to this condition, the sterilization issue reported by the customer could not be replicated and confirmed.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported force sensor error.Investigation findings: no findings available (c20)/ investigation conclusions: appropriate term/code not available (d17 were selected as related to the sterile packaging issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17322361
• MDR Text Key: 319021897
• Report Number: 2029046-2023-01512
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 31029876L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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: THMCL SMTCH SF UNID, TC, F; THMCL SMTCH SF UNID, TC, F; THMCL SMTCH SF UNID, TC, F; UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND CABLE; UNK_CARTO 3