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

Catalog Number D134701

Device Problems Device Contamination with Chemical or Other Material (2944); Sharp Edges (4013); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

The device evaluation has been completed.The catheter was inspected and white material was observed under ring #2, also the ring appear to be lifted.Then, electrical test was performed on the catheter and it was found within specifications, however, the thermocouple values were found out of spec.A failure analysis was performed and it was found that there is an electrical intermittence on the tip area creating the temperature issue.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that white particle is primarily composed of a polyethylene-based material with barium sulfate-based material.This composite material is widely used as radio pacifier along medical devices industries.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, stress marks, scratches.A sharp edge is observed.It is possible that the damage was generated with an unknown object.No other anomalies were observed.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.Temperature failure is detectable in production, however, the wires can brake during the procedure due to the manipulation of the device.This failure does not represent any patient safety impact.The root cause of the damage ring and the foreign material observed underneath cannot be determined 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 catheter with the preface, however, this cannot be conclusively determined.Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an left atrial tachycardia ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a temperature issue occurred.It was reported that there was no temperature being displayed on the smartablate generator.After the temperature stopped displaying, they were not able to ablate.The cable was replaced with no resolution.When the thermocool® smart touch® sf uni-directional navigation catheter was replaced, the issue resolved.No patient consequence was reported.The issue of no temperature is not mdr reportable since the potential that it could cause or contribute to death or serious injury or other significant adverse event is remote.The complaint product was returned to biosense webster inc.¿s (bwi) failure analysis lab (fal) for evaluation.On 11/12/2018.Initial visual analysis noted the returned device appeared normal.A second visual analysis performed on 11/27/2018, identified a internal part (white matter) was found protruding from under ring 2.Ring 2 appears to be lifted.These findings of foreign material and lifted rings are mdr reportable.On 12/18/2018, a scanning electron microscope (sem) test results shows the ring is lifted.There is evidence of mechanical damage, stress marks, scratches.A sharp edge is observed.These findings continued to be considered mdr reportable malfunction.This event was originally considered nonreportable, however, bwi became aware of a reportable malfunction through visual analysis on 11/27/2018 and has reassessed this complaint as reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 8192527
• MDR Text Key: 132063875
• Report Number: 2029046-2018-02488
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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: 11/27/2018

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: 06/10/2019
• Device Catalogue Number: D134701
• Device Lot Number: 30064098L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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