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 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 6/7/2018.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.Concomitant medical products: smartablate¿ system rf generator (model#: m-4900-07, serial#: unknown).Manufacturer ref no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter, and during ablation high impedance displayed on the generator.The smart ablate generator was used.Generator parameters were set to power mode and temperature cut off was set at 39o celsius.Impedance started at 1:20 and increased to 200+.The system stopped ablation when the cut off values were exceeded.The catheter was replaced and the issue resolved without patient consequence.High impedance is not reportable.The potential it could cause or contribute to a serious injury or death is remote.Therefore, the observed high impedance has been assessed as not reportable.This event is being reported because the bwi failure analysis lab received the device on for evaluation and the (b)(6) 2018 fal findings of product having char on catheter distal tip with white colored fibrous foreign material stuck in the char.The foreign material found stuck to the char on the catheter tip is a reportable issue.Therefore, this complaint has been assessed as reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter, and during ablation high impedance displayed on the generator.The device was inspected and char was found on the tip and white colored fibrous foreign material was stuck in the char.However, during the second visual inspection the fiber was not observed.Electrical testing was performed and the catheter failed.No electrical readings were observed on electrode # 2.Failure analysis testing was performed and the catheter was dissected on the tip area.The electrical wire was found broken causing the improper electrical signal.Additionally, the catheter was tested on the generator and both the temperature and impedance values were observed to be within specifications.A cool flow pump test was performed and it was found to be within specifications.The catheter was irrigating correctly.No irrigation issues were observed.Additional information was received on 7/9/2018.The manufacture date: 2017/12/08 and expiration date: 2018/12/07 have been added to the corresponding fields of this report.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.Char is a physical phenomenon of radio frequency rf.It can be the normal result of the ablation process.The root cause of both the observed fiber and the electrical breakage, cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).

• 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 92618
• MDR Report Key: 7665044
• MDR Text Key: 113310680
• Report Number: 2029046-2018-01769
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 07/03/2018

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: 12/07/2018
• Device Catalogue Number: D134804
• Device Lot Number: 17766923L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/03/2018
• Supplement Dates FDA Received: 07/26/2018
• Patient Sequence Number: 1