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

Model Number D134804

Device Problem High Readings (2459)

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

Event Date 10/24/2022

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 for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that the ablation catheter displayed high force readings on the carto 3 system after zeroing appropriately.No errors were displayed.The ablation cable was replaced without resolution.The catheter was replaced, and the issue resolved.The case continued without further incident or harm.The customer¿s reported issue of ¿high force¿ is not considered to be mdr reportable since 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.On 20-dec-2022, the bwi pal revealed that a visual inspection of the returned device found a reddish-brown material inside a hole in the pebax area of the device.This finding was reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the catheter was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and spi screening test of the returned catheter.Visual analysis of the returned catheter revealed reddish-brown material inside and a hole in the pebax of the device.The spi screening test was performed, in accordance with bwi procedures.The returned sample was connected to carto3 system, and the force values were observed within specifications.The evaluation determined that the cause of pebax damage failure cannot be established.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter be disconnected.If the problem persists, replace the catheter cable or the catheter.The events described force issue were unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.As part of bwi¿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 ref#: (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: 16191292
• MDR Text Key: 308926442
• Report Number: 2029046-2023-00107
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Report Date: 01/17/2023

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 Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30887175L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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: CARTO 3 SYSTEM; UNKNOWN CATHETER CABLE