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

Catalog Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis has been completed.The device was visually inspected and sharp white internal part protruding under ring 1 was observed.Ring 1 appeared to be lifted.Then, the catheter outer diameter was measured and it was found within specification.Scanning electron microscope (sem) testing was performed on the damaged area.The results showed evidence of mechanical damage on the surface of the ring and a sharp edge was found.It is possible that the damage was generated with an unknown object.No other anomalies were observed.In addition, fourier transform infrared spectroscopy testing (ftir) was performed and the results showed that the white particle is primarily composed of a polyethylene-based material with barium sulfate-based material.This composite material is widely used as radio pacifier along medical device industries.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 root cause of the damage on the ring cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

On july 27, 2018, a thermocool® smart touch® sf bi-directional navigation catheter was received by the biosense webster failure analysis lab as an extra product under (b)(4).(b)(4) was assessed as not reportable for a deflection issue.The first visual finding from the biosense webster failure analysis lab for this extra product was a visual finding of a sharp white internal part protruding under ring 1.Ring 1 appeared to be lifted.The issue of ia lifted electrode with sharp ring edges has been assessed as reportable.An investigation was performed to determine if there was an existing manufacturer reference number for this extra product received.Additional information was received stating that this product does not belong to any complaint.Therefore, since we were unable to determine if there is an existing manufacturer reference number and the returned catheter condition has been assessed as a reportable malfunction, we have made the decision to create a related (b)(4) to conservatively report this returned catheter condition.

Manufacturer Narrative

Device evaluation summary: upon receipt, the device was visually inspected, and sharp white material was found protruding out from under the first electrode, which appeared to be lifted.The outer diameter of the catheter was measured, and was found within specification.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 the sharp edge.It is possible that the damage was caused by contact with an unknown object.No other anomalies were observed.In addition, fourier transform infrared spectroscopy (ftir) analysis was performed, and the results showed that the white material is primarily composed of a polyethylene-based material with barium sulfate-based material.This composite material is widely used as a radio pacifier in the medical device industry.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 catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The root cause of the damage on the ring 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® 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: 7816598
• MDR Text Key: 118751360
• Report Number: 2029046-2018-01987
• 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
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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: 07/31/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17705291L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1