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

Catalog Number D134805

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that there was contamination of the spring part with blood.The issue occurred 30 minutes after use and the issue was resolved when the catheter was exchanged.After that, the procedure was successfully completed.The issue of blood contamination is not considered to be mdr reportable since there was no report of damage to the pebax integrity that could cause the foreign material to travel into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Surface scratches to the pebax sleeve that do not penetrate the pebax should be included in this classification.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax and foreign reddish material was observed inside it.These findings were reviewed and assessed as an mdr reportable malfunction since the integrity of the device is compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed a hole in the pebax and foreign reddish material was observed inside it.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The customer complaint regarding the force vector inverted was not duplicated however, the foreign material inside the pebax could be related to this issue.The observed damage could be related to the procedure.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 instructions for use contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.E1.Initial reporter phone: (b)(6).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: 17408817
• MDR Text Key: 320130589
• Report Number: 2029046-2023-01619
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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
• Report Date: 07/27/2023

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: 30922841L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; SMARTABLATE PUMP KIT (JAPAN); UNKNOWN GENERATOR