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 06/22/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) 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 surface of the tip area (pebax).During the procedure, they noticed that there was a little bit of blood that had gotten into the proximal area by the tip near the springs in the catheter.To troubleshoot, the catheter was replaced.The issue was resolved and the procedure was continued.There is no patient consequence reported.Additional information was received.The vizigo 8.5 french sheath was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax did not appear to be physically damaged.A picture was not available.The issue reported of ¿blood that had gotten into the proximal area by the tip near the springs in the catheter¿ was assessed as non mdr reportable.Foreign material was found underneath the pebax.However, there is no damage to the pebax integrity.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 21-aug-2023, observed reddish material inside the pebax and a hole on the surface of the tip area.The hole on the surface of the tip area (pebax) was assessed as mdr reportable.The awareness date for this reportable lab finding was 21-aug-2023.

Manufacturer Narrative

The device evaluation was completed on 21-aug-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that there was a reddish material inside the pebax and a hole on the surface of the tip area.The root cause of the hole at the pebax cannot be determined; however, based on the information available, the condition observed most likely originated in someplace external to the manufacturing environment.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.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 (ifu) contain the following recommendations: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 17749309
• MDR Text Key: 323634316
• Report Number: 2029046-2023-02076
• 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: 09/14/2023

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: 31056603L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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