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

Catalog Number D132705

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The first visual analysis was performed and a brownish material was observed under the pebax.During the second visual analysis a brownish material observed under the pebax and a hole was also observed in the pebax.The root cause of hole on pebax cannot be determined.Then, the magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.The force sensor feature was tested and it was working properly, the force values were observed within specifications.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the damage on the pebax 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¿ 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 they encountered force sensor errors and system couldn´t zero the catheter.After replacing the catheter cable, the force sensor error with the catheter was not solved.This thermocool® smart touch¿ bi-directional navigation catheter was replaced with another one of the same type to continue the procedure and it was completed successfully.There was no noise and there were no patient consequences.The customer¿s reported ¿force sensor¿ issues are not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 10/1/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found ¿brownish material observed under pebax.¿ this finding was considered to be not reportable since there was no visible external damage and therefore the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 11/6/2019, during a second visual inspection, the catheter was inspected and a brownish material was observed under the pebax, a hole observed in the pebax.This finding was assessed as a mdr reportable malfunction.This event was originally considered nonreportable, however, bwi became aware of a reportable malfunction through visual inspection on 11/6/2019 and has reassessed this complaint as mdr reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 9394817
• MDR Text Key: 194787954
• Report Number: 2029046-2019-03943
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031/S053
• 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: 07/11/2019

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 Expiration Date: 03/24/2020
• Device Catalogue Number: D132705
• Device Lot Number: 30195706M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• 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