MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1348-02-S

Device Problems Break (1069); Hole In Material (1293); Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant products: st.Jude medical agilis small curl 8.5fr sheath.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where the tip broke and filled with blood.The damage did not result in any lifted/sharp rings, nor any exposed wiring.There was no detachment of catheter components, and no difficulty was noted during insertion or removal of the catheter.The catheter was replaced, and the case continued without any report of patient consequence.Blood is an expected finding after this type of procedure, and is not mdr reportable.Since there were no lifted/sharp rings, no exposed wiring, this event was not considered mdr reportable.On (b)(6) 2016, the biosense webster failure analysis lab noted a break in transition between the spine cover and tip of the catheter.However, the catheter integrity was maintained, and no internal components were found to be exposed.This was also not considered an mdr reportable finding.Also on (b)(6) 2016, the catheter underwent scanning electron microscope analysis, where it was found that the pebax exhibited evidence of scratches and pinholes.This exposes the patient to the internal components of the catheter, creating a risk of thrombus.As a result, this event is mdr reportable.The awareness date of this complaint was reset to (b)(6) 2016, as that is when the reportable findings were discovered by the biosense webster failure analysis lab.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool smart touch bidirectional sf catheter where the tip broke and filled with blood.The returned device was visually inspected, and a bump was found near the peek housing/lumen transition, as well reddish material near the pebax area.Per this condition, scanning electron microscope (sem) analysis was performed over the pebax area, and it was found that the external surface of the pebax exhibited evidence of scratches and pinholes.It is possible that an unknown object hit and ruptured the pebax.Due the bump observed, the catheter was dissected, and it was found that the t-bar slid out of place.Reddish material was observed in the dissection area due the t-bar issue.Polyurethane residues were also found near the t-bar.The dacron assembly was in the correct position, indicating proper assembly during manufacturing.Additionally, catheter deflection is verified several times before leaving the facilities.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.The pebax was found damaged.Based on available analysis results, it cannot be identified whether the issue is related to an internal or an external cause.The root cause of the t-bar displacement cannot be determined, as there was evidence of proper assembly during manufacturing.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6211051
• MDR Text Key: 63756606
• Report Number: 9673241-2016-00913
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: (01)10846835010152(11)160705(17)170630(10)17500005L
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: D-1348-02-S
• Device Catalogue Number: D134802
• Device Lot Number: 17500005L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2016
• 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