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

Catalog Number D134702

Device Problems Material Frayed (1262); Device Sensing Problem (2917); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Product investigation: the device was visually inspected and blood was found inside the tip.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly, the force values were observed within specifications.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.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 damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of the damage on pebax cannot be determined, in addition, there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported a patient underwent a procedure with a thermocool® smart touch® sf uni-directional navigation catheter and it was reported there was blood inside the tip of the sensor.During the case there was erratic readings on the force.The catheter was then removed and there was blood on the tip of the catheter.This happened at the end of the case.There was no patient consequence and the issues of erratic force reading and blood inside the catheter tip are not reportable issues.On 04/18/2018, the bwi failure analysis lab received the device for evaluation.Initial visual analysis found the catheter appeared in good normal condition but with blood on the tip.On 05/04/2018, further product evaluation which included scanning electron microscope (sem) testing found, evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.¿ the issue of a hole being found on the pebax is considered a reportable malfunction.As such, the awareness date for this record is 05/04/2018 because this is when the reportable malfunction was identified by the bwi failure analysis lab.

• 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: 7551457
• MDR Text Key: 109901513
• Report Number: 2029046-2018-01606
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: 05/04/2018

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: 11/09/2018
• Device Catalogue Number: D134702
• Device Lot Number: 17752440L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• 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