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

Model Number D134805

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed that the smart touch bidirectional sf has a superficial cut at the middle section of the shaft with an exposed braid.The damage to the shaft could be related to the handling of the device during shipment.Deflection testing was performed, in accordance with bwi procedures.The deflection mechanism pass the test, the curve met the specification.A manufacturing record evaluation was performed for the finished device 30673177l number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The event described could not be confirmed as the device was found with the deflection curve within specifications, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a superficial cut with an exposed braid in the middle section of the shaft.The finding was identified on (b)(6) 2022.It was initially reported by the customer that during the procedure there was a strange feeling in how the catheter curved.The issue occurred during gap ablation.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.Deflection issue is not mdr-reportable.Broken shaft (mid shaft) is mdr-reportable.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14421685
• MDR Text Key: 294533602
• Report Number: 2029046-2022-01035
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30673177L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2022
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2021
• 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