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

Catalog Number D134805

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.It was reported that when the ablation was activated, a "high force" message would be displayed on the carto 3 system.The issue persisted despite multiple re-zeroings.The catheter cable was replaced without resolution.The catheter was replaced and the issue resolved.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 22-nov-2023, observed a hole in the pebax.In addition, reddish material was inside the pebax.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax on 22-nov-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 23-oct-2023.The device evaluation was completed on 22-nov-2023.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 that there was a hole in the pebax.Reddish material inside the pebax was also observed.The damage could be related to excessive force or manipulation, but this cannot be conclusively determined.The root cause of the hole remains unknown.Also, the device was connected to carto 3 system and the device was recognized and visualized; however, inverted force vector appeared in the system with high force readings.The device was further analyzed and no additional defects were found on the printed circuit board or any other component.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The force issue reported can be confirmed due to the condition observed in the pebax.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.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: 18361465
• MDR Text Key: 331074761
• Report Number: 2029046-2023-03012
• 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: 12/19/2023

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: 31119640L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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: UNKNOWN BRAND CATHETER CABLE; UNK_CARTO 3