MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Positioning Problem (3009)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-jan-2024.The device evaluation was completed on 28-feb-2024.The product was returned to biosense webster (bwi) for evaluation.Visual inspection, a deflection test, and a fourier transformed infrared spectroscopy (ftir) study of the returned evidence were performed following bwi procedures.Visual analysis revealed that ring #2 was lifted and foreign blue material was attached to it.Additionally, the pebax was broken around this area.Deflection testing was performed and the deflection mechanism failed due to the puller wire being broken in the handle.A fourier transform infrared spectroscopy (ftir) study was performed on the material and revealed that this material was mostly composed of polypropylene-based material.The source of the material remains unknown.However, as this material was not used during the manufacturing process, the evidence suggests that this issue occurred outside the manufacturing facilities during the handling of the device.Nevertheless, this could not be conclusively determined.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.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.Explanation of codes: investigation findings: fracture problem (c070603) / investigation conclusions: cause not established (d15) / component code: steering wire (g04121) were selected as related to the customer¿s reported ¿deflection issue¿.In addition, the biosense webster inc.Analysis finding of the ¿puller wire being broken¿.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿foreign blue material¿.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the ¿ring #2 was lifted¿.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿broken pebax¿.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified ring #2 lifted, foreign blue material attached to it and broken pebax issues.Deflection issue.During the procedure, catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on the patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 28-feb-2024, ring #2 was lifted and foreign blue material was attached to it.Additionally, the pebax was broken around this area.This event was originally considered non-reportable, however, bwi became aware of the returned conditions of ring #2 lifted, foreign blue material attached to it and the broken pebax issues on 28-feb-2024 and have assessed these returned conditions as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 18923736
• MDR Text Key: 337905577
• Report Number: 2029046-2024-00873
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31141066M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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