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

Catalog Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi product 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.A manufacturing record evaluation was performed for the finished device 30039955l number, and no non-conformances was found during the review.Please note, follow up attempts are in progress requesting english translation of the initial reporter facility name.When the information is received, a supplemental 3500a report will be submitted.Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster inc.(bwi) has identified a foreign material inside the catheter.It was reported that during the ablation procedure, the thermocool® smart touch® sf bi-directional navigation catheter encountered unspecified sensor errors related to temperature, magnetic and force.Visualization and noise issues were also encountered on certain recording channels; however the noise was only observed on the ablation catheter signal.The physician did have another electrocardiogram (ecg) signal available to monitor the patient¿s heart rhythm.The customer troubleshot the issue by checking the calibration with the thermocool® smart touch® sf bi-directional navigation catheter and then tried replacing the catheter cable with no resolution.They powered down the patient interface unit (piu) and the workstation but that did not resolve the issues either.Finally, they replaced the thermocool® smart touch® sf bi-directional navigation catheter and the issues resolved.No patient consequence was reported.The customer¿s reported event has been assessed as not reportable as it relates to the issues of sensor errors, visualization and noise since the potential risk that these could cause or contribute to a serious injury or death is remote.However, on 1/29/2019 during product evaluation of the returned catheter, the bwi product analysis lab conducted a fourier transform infrared spectroscopy analysis which revealed ¿foreign material that is primarily composed of cellulose base material was found inside the irrigation tube.This kind of material is widely found in the textile fibers, paper, clothes, etc.However, the source of origin remains unknown.¿ this finding has been assessed as an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through ftir analysis on 01/29/2019 and has reassessed this complaint as reportable.

Manufacturer Narrative

On 2/21/2019, the english translated initial reporter facility name was received as ¿b)(6)" initial reporter facility name has been updated.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

It was reported a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster inc.(bwi) has identified a foreign material inside the catheter.It was reported that during the ablation procedure, the thermocool® smart touch® sf bi-directional navigation catheter encountered unspecified sensor errors related to temperature, magnetic and force.Visualization and noise issues were also encountered on certain recording channels; however the noise was only observed on the ablation catheter signal.The physician did have another electrocardiogram (ecg) signal available to monitor the patient¿s heart rhythm.The customer¿s reported event has been assessed as not reportable.On 1/29/2019, during product evaluation of the returned catheter, the bwi product analysis lab conducted a fourier transform infrared spectroscopy analysis which revealed ¿foreign material that is primarily composed of cellulose base material was found inside the irrigation tube.This kind of material is widely found in the textile fibers, paper, clothes, etc.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.A magnetic sensor functionality was tested on carto and the catheter failed, error 105 was observed.Failure analysis was performed.The catheter was dissected and the sensor values were found within specifications.With this information, the failure can be attributed to a potential pc board failure.An electrical test was performed on the catheter and it was found within specifications; no electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, an irrigation test was performed and the catheter failed.The catheter was dissected and foreign material was found inside the irrigation tube.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material is primarily composed of cellulose base material, this kind of material is widely in the textile fibers, paper, clothes, etc.However, the source of origin remains unknown.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The cellulose issue was previously investigated and it was concluded that: none of the particulate samples taken from the production line showed a material spectrum matching the one given by the foreign material found in the complaint device.Additionally, none of the materials used in the manufacturing process that are either part of the catheter assembly or have direct contact with its components produced have an ftir spectrum profile that matched the one from the complaint device.However, it was not identified as a material endemic to the manufacturing floor environment since the material used on the assembly floor does not contain cellulose base material.Finally, there are multiple different test performed in the production floor that help to prevent and/or detect the occlusion of the irrigation path during the manufacturing of the device.The root cause of the pc board failure cannot be related to the manufacture process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the interaction of the device with other equipment during the procedure, however, this cannot be conclusively determined.Manufacturer¿s ref # (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 CA 92618
• MDR Report Key: 8359440
• MDR Text Key: 140172436
• Report Number: 2029046-2019-02718
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30039955L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1