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 Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed 11/22/2019.The device was inspected, and reddish-brown color was observed under the pebax.During the second visual the reddish-brown color under pebax was confirmed.In addition, a cut was observed in the pebax.The magnetic sensor functionality was tested on the carto and the catheter was properly visualized, with no errors were observed.A manufacturing record evaluation was performed and no internal actions were found during the review.The customer complaint cannot be confirmed.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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a cut in the pebax.Initially, it was reported that magnetic sensor errors 104, 401, and 402 displayed.The cable was replaced but the issue remained.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed magnetics sensor errors have been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The bwi pal received the device for evaluation.Upon initial visual inspection, the bwi pal observed reddish brown material under the pebax.Further testing was performed.During a second visual inspection on 11/19/2019, the initial finding of reddish-brown material under the pebax was confirmed.Additionally, a cute in the pebax was observed.The observed cut in the pebax has been assessed as an mdr reportable malfunction as the device integrity was compromised.The awareness date has been reset to 11/19/2019.

• 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: 9477503
• MDR Text Key: 200801863
• Report Number: 2029046-2019-03996
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30243743M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2019
• 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