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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and a carto test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Carto test was performed, in accordance with bwi procedures.Magnetic sensor functionality was tested on the carto and the catheter failed, error 105 was observed.A failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The issue reported could be related to the blood observed inside the pebax.The root cause of the pebax damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through bwi¿s quality system.The instructions for use contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was reported that the thermocool® smart touch® sf bi-directional navigation catheter was moving "oddly" on the carto 3 system.Caller stated the position of the thermocool® smart touch® sf bi-directional navigation catheter was not accurate.It was reported that when the thermocool® smart touch® sf bi-directional navigation catheter was removed from the body, there was blood in the clear tip of the catheter.When the catheter was replaced, the issue resolved.The carto 3 system is operating per specs and is not responsible for the product issue.The procedure was continued.The reporter believes the blood was inside the pebax.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The reporter is not sure if catheter pebax was physically damaged.The customer¿s reported issue was assessed as not reportable since no damage to the pebax integrity was reported that could cause the foreign material to travel into the blood circulation.The potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.On 7-jul-2021, the bwi product analysis lab received the complaint device for evaluation.On 16-july-2021, the device was inspected and it was found with a reddish material inside the pebax and a hole in the pebax.Internal metals are exposed.This finding of hole in pebax with internal components exposed is considered to be an mdr reportable malfunction.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 11-aug-2021, it was noticed that an incorrect statement was reported in section h10.Additional manufacturer narrative of the 3500a initial medwatch report.Please consider the following correction: the incorrect statement is: "visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter." the correct statement is "visual analysis of the returned sample revealed that it was found with a reddish material inside the pebax and a hole in the pebax.Internal metals are exposed.".

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12306620
• MDR Text Key: 265992483
• Report Number: 2029046-2021-01323
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30487632M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; ST. JUDE MEDICAL SR0 8.5F SHEATH; THMCL SMTCH SF BID, TC, D-F; CARTO 3 SYSTEM; ST. JUDE MEDICAL SR0 8.5F SHEATH; THMCL SMTCH SF BID, TC, D-F