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

Catalog Number D134804

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 30010878l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and a foreign material on the catheter tip issue occurred.It was reported that at the end of the case, some type of ¿paper¿ was noticed on the tip of the thermocool® smart touch® sf bi-directional navigation catheter after it had been removed from the patient¿s body.The caller reported that while the doctor tried to remove it, it seemed to have fibers, however it was confirmed to not be patient tissue or char.There was no patient consequence.The issue of ¿foreign matter¿ has been assessed 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8136544
• MDR Text Key: 130049299
• Report Number: 2029046-2018-02415
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 11/07/2018

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: 02/12/2019
• Device Catalogue Number: D134804
• Device Lot Number: 30010878L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2018
• Initial Date FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2018
• 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