MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Failure to Sense (1559)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 16-aug-2023.The device evaluation was completed on 25-sep-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed reddish material inside the pebax and a hole in its surface.Screening test was performed, and the device was recognized and visualized on the system; however, error 106 was displayed on the screen due to the pebax damage and reddish material inside of it.The root cause of the damage on the pebax could not be conclusively determined; however, it was concluded that it could be related to the issue described by the customer.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 31042964m, and no internal action was found during the review.The visualization issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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.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 pvc procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax surface.Force sensor error.During the procedure, error 106 was displayed on the carto system.A second device was used to complete the procedure.There was no adverse event reported on the patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 25-sep-2023, it was observed that there was reddish material inside the pebax and a hole in its surface.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax surface on 25-sep-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) the product investigation was reopened to correct the investigation findings which resulted in the following changes/corrections on 07-nov-2023.Initially we reported in the 3500a initial report in the investigation findings, ¿the visualization issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.¿ however, it should have stated, ¿the issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.¿.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 17994997
• MDR Text Key: 326371055
• Report Number: 2029046-2023-02392
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2024
• Device Catalogue Number: D133604IL
• Device Lot Number: 31042964M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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: UNK_CARTO 3