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

Catalog Number D134702

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 12/11/2018 and found a black spot at the transition.These findings confirm the damages observed by the customer.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.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.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient and underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and on the catheter shaft, dark spot foreign material was observed.The foreign material which was described as dark spot, was a few inches back from the visualization electrode.It was noticed right out of the package and never went into the body.The physician tried to scrape it off with no success.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed dark spot foreign material has been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient and underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and on the catheter shaft, dark spot foreign material was observed.The investigational analysis completed on 1/30/2019.The device was inspected and a black spot was observed at the transition.During the second visual inspection, it was clarified that a black marker spot was observed on the shaft.No foreign material or exposed material was observed.The manufacture team performed an investigation in order to determine the root cause.Investigation results determined the issue is related to the manufacturing process involving the force calibration station, since the mark placed in the normal process has the same characteristics mentioned in the comparison.An awareness session was performed for the operators.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.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, however, during the investigation of the condition reported, it was concluded that this issue was not detected by the inspections on the line.Afterwards, there is no potential harm and the risk is consider low.The customer complaint has been verified since the dark spot was confirmed.No foreign material was observed.Based on available analysis results, the complaint appears to be caused by internal biosense webster inc.(bwi) operations, specifically the manufacturing process.However, this appears to be an isolated case.Manufacture reference no: (b)(4).

• 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
• MDR Report Key: 8165116
• MDR Text Key: 130625495
• Report Number: 2029046-2018-02457
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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: 07/04/2019
• Device Catalogue Number: D134702
• Device Lot Number: 30077112L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1