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

Catalog Number D134805

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected and the product revealed no physical damage.Then, during the second visual a hole was found in the pebax, this condition could be caused due to an external object.Electrical test was performed on the catheter and it failed.A failure analysis was performed and it was found an electrical wire broken creating the electrical issue.A manufacturing record evaluation was performed for the finished device with lot number 30255902m, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the damage on the pebax and electrical wire breakage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab has identified a hole on the pebax.It was initially reported by the customer that during the procedure, after the map was created by soundstar, mapping was started.A signal noise occurred only at the ablation electrical potentials.Surrounding environment was checked, the cable was changed, the carto 3 system was rebooted but the issue continued.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.The procedure was completed without patient's consequence.The customer¿s reported noise on signals issue is not mdr reportable since the risk to patient is low.On (b)(6) 2019, the bionsense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.Initial visual inspection revealed no physical damage.On (b)(6) 2019, during a second visual inspection a reddish material was observed inside of the pebax and a detailed inspection revealed a hole in the pebax.Everything else looked normal.These findings were reviewed and determined the complaint is mdr reportable for the malfunction of hole in the pebax.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual inspection on (b)(6) 2019 and reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9528255
• MDR Text Key: 200012716
• Report Number: 2029046-2019-04071
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30255902M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• 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