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

Catalog Number D134805

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection of the returned device was performed following bwi procedures.After conducting a visual analysis, it was discovered a hole in the pebax, exposing internal components of the device.Additionally, blood was observed inside the pebax.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The root cause of the pebax damage could be related to the manipulation of the device during the procedure however, this cannot be conclusively determined.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia 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 after removing the thermocool® smart touch® sf bi-directional navigation catheter from the body, it was noticed that there was blood present underneath the plastic clear tip on the end of the thermocool® smart touch® sf bi-directional navigation catheter, but no physical damage was noticed.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The procedure continued.There was no patient consequence.The customer¿s reported issue of blood inside the clear plastic tip is not considered to be mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 31-jul-2023, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax exposing internal components of the device.Additionally, blood was observed inside the pebax.These findings were reviewed and determined the issue of ¿hole¿ in the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.

• 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: 17610733
• MDR Text Key: 321816965
• Report Number: 2029046-2023-01851
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2023

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: 31012971L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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: SOUNDSTAR ECO GE 8F CATHETER