MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMARTTOUCH,TC,D,C3,OBL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 10/18/2018.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) for the lot number 30021807m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an deflection issue occurred.During the operation, the catheter could not deflect to the specification.A second catheter was used to complete the operation.No adverse patient consequences were reported.The deflection issue has been assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because on (b)(4) 2018 the bwi failure analysis lab (fal) received the device for evaluation and found dark red / brown material between the tip and ring 1.The presence of char is not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event was originally considered not-reportable.However, during a second visual inspection on (b)(4) 2018 ,the bwi fal observed foreign material like fibers on the dome holes and have reassessed the event as reportable.The foreign material like fibers observed on the dome holes has been assessed as mdr reportable.The awareness date was reset to (b)(4) 2018.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an deflection issue occurred.Additional information was received on 11/16/2018, indicating the device history record (dhr) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacture reference no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an deflection issue occurred.The device was inspected and reddish black foreign material was observed on the tip.During a closer inspection, foreign material was observed on the dome holes.Electrical testing 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.Deflection testing was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x ray machine.The t bar was found slid down causing the improper deflection condition.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material was primarily composed of cellulose-base material.This kind of material is widely used in textile fiber, paper, clothes,and etc.However, the source of origin remains unknown.For this condition, the manufacture team performed an investigation in order to find the root cause.The investigation results showed that this issue is not related to the manufacture process since the material found is not used in the production floor.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 the 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 was confirmed.The root cause of the t bar slippage cannot be determined, however, an internal corrective action has been opened to investigate this issue.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 an ftir spectrum profile that matched the one from the complaint.However, it was not identified as a material endemic to the manufacturing floor environment.There were multiple different tests performed on the production floor that helped to prevent and or detect the occlusion of the irrigation path during the manufacturing of the device.The char observed on the catheter tip could be related to the occlusion of the device.Char is a physical phenomenon of radio frequency.It can be the normal result of the ablation process.Manufacture ref no: (b)(4).

• Brand Name: THMCL SMARTTOUCH,TC,D,C3,OBL
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8075225
• MDR Text Key: 128439709
• Report Number: 2029046-2018-02282
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 10/08/2018

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: 02/25/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30021807M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 04/25/2019
• Supplement Dates FDA Received: 12/11/2018; 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1