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); Failure to Sense (1559); Contamination /Decontamination Problem (2895)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) 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 carto 3 system displayed error 106 (force sensor error) and error 80 (invalid force measurements.) when the catheter was connected to the piu.The caller stated that the force reading was displayed on the carto 3 system as "hi" even though the catheter wasn't touching anything.They pulled the catheter out to inspect the catheter and it was discovered that there was visible blood inside the tip of the catheter around the electrode.The catheter was replaced and the issue was resolved.The procedure was continued.Additional information received indicated there was no difficulty with the maneuverability of the device and there was no physical damage.A carto vizigo¿ 8.5f bi-directional guiding sheath was used during this procedure.The customer¿s reported force and blood in the tip issues are not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2023, the bwi pal revealed that a visual inspection of the returned device found a reddish material inside the pebax and a hole leaving internal components exposed.These findings were reviewed and determined the issue of a hole in the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax and a hole leaving internal components exposed.The device was connected to carto 3 system and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.The root cause of pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.However, it could be related to the handling of the device during the procedure, but this cannot be conclusively determined.This issue could be contributed to the force issue reported by the customer.Additionally, a picture was received for evaluation from the customer.According to pictures provided by the customer, reddish material (presumably blood) was observed inside the pebax; however, no external damages were observed on the device.The blood inside the pebax could be related to the force issue reported by the customer; however, this cannot be conclusively determined.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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.Explanation of codes: investigation findings: open circuit (c0205)/investigation conclusions: cause not established (d15)/component code: sensor (g03012) were selected as related to the customer reported force issues.Investigation findings: material and/or chemical problem identified (c06)/investigation conclusions: unintended use error caused or contributed to event (d1102)/component code: sleeve (g04115) were selected as related to blood and hole in the pebax.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: 17578044
• MDR Text Key: 321550959
• Report Number: 2029046-2023-01807
• 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: 08/18/2023

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: 31010103L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/18/2023
• 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: UNK_CARTO VIZIGO SHEATH