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

Catalog Number D133604IL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Deformation (2976)

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

Event Date 09/09/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a pebax broken issue.Initially it was reported that during the procedure, error code '88' was displayed at the time of ablation.After withdrawing the catheter from the patient, it was found that the tip of the device had been damaged.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received.The damage did not result in wires being exposed.Unknown if the damage resulted in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue was between the 2nd and 3rd electrode.Unknown if the catheter was pre-shaped.A vizigo sheath was used.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 29-nov-2023, the device tip was inspected under microscope and the pebax was observed twisted with reddish material inside and broken.This event was originally considered non-reportable, however, bwi became aware of the pebax broken on 29-nov-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

E1: (b)(6).The investigation was completed on 29-nov-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, inverted force vector and alert 88 "force reading accuracy might be reduced" were observed on the carto 3 screen.In addition, the force value was observed at 50g on the carto 3 screen.This value could be considered a high force value; however, this cannot be conclusively determined.Also, the pebax was observed abnormal with no sharp edges or wires exposed but due to photo provided, no damage type could be conclusively determined.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed a foreign material inside the tip.The magnetic and force feature were tested.The force values and the vector were observed within specifications.No force issues were observed.The device tip was inspected under microscope after performed the test, and the pebax was found twisted, with reddish material inside and broken.It was determined that the damage and the foreign material observed was sustained in someplace external to the manufacturing environment and could be related to the force issue reported by the customer.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: 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.If the force problem persists, replace the catheter cable or the catheter.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.Explanation of codes: investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the photo provided and to the customer¿s reported ¿error code '88'¿ force issue and the damaged tip.Investigation findings: software problem identified (c10) / investigation conclusions: cause not established (d15) were selected as related to the customer¿s reported ¿error code '88'¿ force issue.Investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿error code '88'¿ force issue and the biosense webster inc.Analysis finding of the ¿pebax twisted with reddish material inside and broken¿.Manufacturer's reference number: (b)(4).

• 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: 18406450
• MDR Text Key: 332404761
• Report Number: 2029046-2023-03095
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 31070928M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2023
• 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