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

Catalog Number D134805

Device Problems Display or Visual Feedback Problem (1184); Material Puncture/Hole (1504)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the bwi product analysis lab identified a hole in the pebax with reddish material inside.During the procedure, the catheters were visibly "shaking" on the carto 3 system display.The ablation cable was replaced without resolution.The indifferent electrodes were moved to the leg of the patient.No visual damage to the patient interface unit (piu) mapping port.Catheter was replaced with a different lot number and the issue resolved.No patient consequences were reported.The "shaking" issue on the display is not mdr-reportable.The hole in the pebax is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax.The device was connected to the carto 3 system and it was recognized and visualized correctly.No issues or errors were observed.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.The tip was cut and the pebax was microscopically inspected, holes in the pebax area were observed.Even though no visualization issues were observed during testing, the reddish material inside the pebax may be related to the issue described by the customer; however, the root cause of the damage in the pebax area could not be conclusively determined.A manufacturing record evaluation was performed for finished device number 30980900l, and no internal action was found during the review.The 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.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 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17440721
• MDR Text Key: 320205796
• Report Number: 2029046-2023-01671
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2023

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 Catalogue Number: D134805
• Device Lot Number: 30980900L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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: CARTO 3 SYSTEM