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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184); Material Puncture/Hole (1504)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The returned device was visually inspected, and it was found a hole in pebax with reddish material inside.Per the event, the catheter was tested for electrical performance and it was found within specifications.Then, the catheter was connected to carto and the catheter was properly visualized and no errors were observed.A manufacturing record evaluation was performed for the finished device 30376908m number, and no internal action was found during the review.The customer complaint regarding visualization issue was unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.The catheter passed electrical tests.The root cause of the damage on 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 visualization issue and the noise on electrodes concluded the cause could not be established since the catheter passed testing.A mechanical problem was found to be related to the hole in the pebax.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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf 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® sf bi-directional navigation catheter during returned product evaluation.It was initially reported by the customer that when ablation was turned on there was noise on all electrodes of the catheter and its icon disappeared from the carto map.The caller replaced the catheter cable, indifferent electrode grounding pad, and generator and the issue did not resolve.The thermocool® smart touch® sf bi-directional navigation catheter was replaced and the issue resolved.The case continued.There was no patient consequence.The customer¿s reported issues of noise on the electrode and visualization issues with the carto 3 system are not considered to be mdr reportable events since if the device is not visualized by the carto system.The user will have to replace the catheter in order to complete the case.The most likely consequence is an intraprocedural delay and the potential risk that it could cause or contribute to a serious injury or death is remote.On 12/4/2020 during device evaluation, the device was found to have a hole in the pebax and reddish material inside.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 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11102050
• MDR Text Key: 251099310
• Report Number: 2029046-2020-02041
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2020

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: 05/03/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30376908M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2020
• 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