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

Catalog Number D134721IL

Device Problems Signal Artifact/Noise (1036); Contamination /Decontamination Problem (2895)

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

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and all ecg signals were lost.Initially, it was reported that during the procedure, a signal interference noise was observed.A second catheter was used to complete the operation.There was no adverse event reported on the patient.Additional information was received on 24-nov-2021 which confirmed that the signal interference (noise) was observed on all ecg (bs + ic) channels.The signal interference (noise) was observed on carto® and the recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.With the additional information received on 24-nov-2021, this was assessed as a mdr reportable product malfunction.

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and all ecg signals were lost.Initially, it was reported that during the procedure, a signal interference noise was observed.A second catheter was used to complete the operation.There was no adverse event reported on the patient.Additional information was received on 24-nov-2021 which confirmed that the signal interference (noise) was observed on all ecg (bs + ic) channels.The signal interference (noise) was observed on carto® and the recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.With the additional information received on 24-nov-2021, this was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Initial reporter phone: (b)(6).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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially, it was reported that all ecg signals were lost.The biosense webster, inc.Product analysis lab received the device and observed a reddish material inside and a hole on the pebax.The issue with no ecg signal on all channels remains assessed as mdr reportable.The additional finding of the foreign material inside the pebax with external damage was also assessed as mdr reportable.Therefore, h6.Medical device problem code has been updated.The awareness date is (b)(6) 2022.The device evaluation was completed on 24-jan-2022.The device was returned to biosense webster inc.(bwi) for evaluation.A visual inspection and electrical test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed reddish material inside and a hole on the pebax of the device.An electrical test was performed, and an open circuit was found on the tip area.A manufacturing record evaluation (mre) was performed for the finished device 30625058l number, and no internal action related to the complaint was found during the review.Based on the mre, the 4.Expiration date and the h 4.Device manufacture date have been updated.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient; to resolve this situation, verify the proper connection.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13041400
• MDR Text Key: 286131917
• Report Number: 2029046-2021-02221
• 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,Followup
• Report Date: 02/18/2022

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: 08/25/2022
• Device Catalogue Number: D134721IL
• Device Lot Number: 30625058L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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 CATHETER; UNK_CARTO 3