MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problems Device Contamination with Chemical or Other Material (2944); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure 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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and resistance was felt during the withdrawal of the catheter from the sheath.The catheter entered through the sheath with difficulty.It was also reported that after the catheter was removed from the sheath, a small bulge was found on the electrode.  the catheter was replaced to complete the procedure.There was no patient consequence.Additional information was received stating that there were no wires exposed.There was no lifted or sharp rings.The resistance felt during the withdrawal of the catheter is not reportable.The bulge observed on the electrode is also not reportable.The potential risk that they could cause or contribute to a death or serious deterioration in state of health is remote.The device was returned to the bwi failure analysis lab (fal) and on (b)(6) 2018 it was discovered that the product had sharp electrodes on ring 1 with white colored foreign material stuck under it and mechanical damage on the surface of the ring and a sharp edge was found.The issue of foreign material and sharp electrode ring edge is reportable. the awareness date of this reportable finding is (b)(6) 2018.

Manufacturer Narrative

In the initial report, 7/8/2018 was listed as the report submission due date and 7/27/2018 is the correct report submission due date.Additionally, 7/12/2018 was incorrectly reported as the date the device was returned to the manufacturer.The thermocool® smart touch¿ electrophysiology catheter was returned on 6/4/2018.Corresponding fields of this report have been updated accordingly.Manufacture ref no: (b)(4).

Manufacturer Narrative

Device evaluation summary: upon receipt, the device was visually inspected, and electrode #2 was found damaged with foreign material underneath.The catheter outer diameter was measured, and electrode #2 was found out specification due to the damage observed.Scanning electron microscope (sem) analysis was performed on the damaged area, and the results showed evidence of mechanical damage on the surface of the ring, as well as a sharp ring edge.It is possible that the damage was caused by contact with an unknown object.No other anomalies were observed.Fourier transform infrared spectroscopy (ftir) analysis was performed, and the results showed that the foreign material was primarily composed of an acrylonitrile-butadiene-styrene (abs) based material.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 specifications and procedures.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the foreign material underneath the electrode and the damage observed cannot be determined, since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7729245
• MDR Text Key: 115371152
• Report Number: 2029046-2018-01861
• 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: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2018

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: 06/30/2018
• Device Catalogue Number: D133604IL
• Device Lot Number: 17697987M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 07/27/2018; 08/03/2018
• Supplement Dates FDA Received: 08/01/2018; 08/27/2018
• Patient Sequence Number: 1