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

Catalog Number D133604IL

Device Problems Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

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.Still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted to update the expiration date and manufactured date.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a ¿magnetic sensor error¿ occurred.During the procedure, the thermocool® smart touch¿ electrophysiology catheter could not receive magnetic signals and the model could not be built.The thermocool® smart touch¿ electrophysiology catheter was exchanged and the issue resolved.Procedure continued.There were no patient consequences.This event is not mdr reportable.On 6/26/2018, the bwi failure analysis lab identified a ¿whitish material¿ found inside the pebax.The issue was assessed as ¿foreign material¿ inside the pebax as is considered a reportable malfunction.Additionally, scanning electron microscope (sem) analysis revealed evidence of mechanical damage, stress marks, and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The issue of a ¿hole¿ on the pebax is also an mdr reportable malfunction.As such, the awareness date for this record is 6/26/2018 since this is when the first reportable malfunction was identified.

Manufacturer Narrative

It was reported that the thermocool® smart touch¿ electrophysiology catheter could not receive magnetic signals and the model could not be built.The thermocool® smart touch¿ electrophysiology catheter was exchanged and the issue resolved.There were no patient consequences.This event of magnetic signal errors is not mdr reportable.On 6/26/2018, the bwi failure analysis lab identified a ¿whitish material¿ found inside the pebax.The issue was assessed as ¿foreign material¿ inside the pebax and is considered a reportable malfunction.Product evaluation details: the device was visually inspected and slight discoloration of pebax sleeve and whitish material was observed inside the pebax then, the magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.A scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.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.The root cause of the damage on the pebax cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.The manufactured date and expiration date have been provided.Therefore, expiration date and device manufacture date have been populated.Manufacturer's ref # (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: 7716480
• MDR Text Key: 114939106
• Report Number: 2029046-2018-01842
• 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
• Report Date: 06/26/2018

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: 08/22/2018
• Device Catalogue Number: D133604IL
• Device Lot Number: 17717746M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1