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

Model Number D132705

Device Problems Material Puncture/Hole (1504); Positioning Problem (3009)

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

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found reddish material inside the pebax.The inspection also revealed a hole in the pebax.Per the complaint, several tests were performed.An electrical test was performed and the catheter was found in specification: no electrical issues were detected.Also, sensor functionality was tested on carto 3 system and the catheter was found working correctly.Then, the catheter was tested for stockert generator compatibility and it was found within specification.Later, a deflection test was performed and the catheter failed: the tip was not deflected.Finally, cool flow pump and patency flow test were performed and no irrigation issues were detected.A failure analysis was performed and the t-bar was found slid down causing the improper deflection condition.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The customer complaint (deflection issue) was confirmed.The root cause of the t-bar issue could be related to the design of the catheter related to a stress problem.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.The cause cannot be established for the mechanical problem finding.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab identified external damage (a hole) on the pebax of the thermocool® smart touch¿ bi-directional navigation catheter during returned product evaluation.It was initially reported by the customer that during the procedure a deflection issue occurred.It was described as the ¿traction not working properly.¿ there was no patient consequence.The procedure was completed after replacing the thermocool® smart touch¿ bi-directional navigation catheter.The customer¿s reported deflection issue was assessed as not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 12/2/2020, the bwi product analysis lab received the complaint device for evaluation.During product evaluation on 12/4/2020, visual inspection found the catheter had a reddish material inside the pebax and a hole in the pebax.These findings were reviewed and determined the issue of hole in the pebax is an mdr reportable malfunction since the integrity of the device has been compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 12/4/2020 and reassessed 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11102988
• MDR Text Key: 251099775
• Report Number: 2029046-2020-02044
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30349002M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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