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

Catalog Number D134721IL

Device Problems Image Orientation Incorrect (1305); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially a force issue was reported.During the procedure, the force values displayed were high.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 (b)(6) 2023 there was reddish material and a hole in the surface of the pebax observed.This event was originally considered non-reportable, however, bwi became aware of the hole in the pebax on (b)(6) 2023 and have reassessed the event as reportable.

Manufacturer Narrative

The investigation was completed on (b)(6) 2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the force value was observed at 73g on the carto 3 screen.This value could be considered a high force value; however, this cannot be conclusively determined.Also, the force vector was observed inverted.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate to find the root cause of the complaint.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 reddish material and a hole in the surface of the pebax.The device was connected to a carto 3 system and the device was recognized correctly; however, errors 106 and 105 appeared on the system due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The force issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.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.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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17873173
• MDR Text Key: 324972996
• Report Number: 2029046-2023-02233
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2024
• Device Catalogue Number: D134721IL
• Device Lot Number: 31033772L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Date Manufacturer Received: 09/11/2023
• 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