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

Catalog Number D134701

Device Problems Material Separation (1562); Contamination /Decontamination Problem (2895); Device Sensing Problem (2917)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and an electrode ring was loose.The physician first ablated with the ablation catheter.It worked well.Then they suddenly had an impedance problem in the middle of the procedure.There was an error message in the generator.It was not due to the neutral electrode.The physician pulled out the catheter and saw that part of the metal housing had come loose.A ring was loose and moving back and forth on the tip of the catheter.The catheter was also bloody on the inside.They replaced the catheter immediately.The detached metal housing is still on the distal part of the catheter.No patient consequence.Additional information was received.There was no resistance or difficulty during insertion or removal of the catheter.Could move the metal up to the tip of the catheter, but it did not go over the catheter tip.It was not pre-shaped.The sheath used was either an slo or sli from abbott.The electrode ring loose issue was assessed as mdr reportable.The reported ¿catheter being bloody on the inside¿ was assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 07-mar-2024.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The physician first ablated with the ablation catheter.It worked well.Then they suddenly had an impedance problem in the middle of the procedure.There was an error message in the generator.It was not due to the neutral electrode.The physician pulled out the catheter and saw that part of the metal housing had come loose.A ring was loose and moving back and forth on the tip of the catheter.The catheter was also bloody on the inside.They replaced the catheter immediately.The detached metal housing is still on the distal part of the catheter.No patient consequence.The device evaluation was completed on 22-mar-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, temperature and impedance test evaluation of the returned device was performed following bwi procedures.Visual inspection revealed reddish material and a hole in the surface of the pebax.In addition, a ring was separated from the tip.The tip and ring were inspected and evidence of properly manufacturing assembly were found.A temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Since blood was observed inside the pebax, this could be related to the impedance issue.The impedance, ring loose, and blood issues reported by the customer were confirmed.The potential cause of the tip damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.The instruction for use (ifu) states: when cleaning the tip electrode, be careful not to twist the tip electrode with respect to the catheter shaft; twisting may damage the tip electrode bond and loosen the tip electrode or may damage the contact force sensor.In addition, to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.Also, to verify compatibility between the sheath and the catheter, advance the catheter through the sheath prior to insertion.Any sheath < 8.5 f is contraindicated.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to customer¿s reported ¿loose ring¿.In addition, the biosense webster inc.Analysis finding of the ¿ring was separated from the tip¿.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿ impedance problem¿ and ¿catheter bloody on the inside¿.Biosense webster inc.Analysis finding of the ¿reddish material and a hole in the surface of the pebax¿.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024 there was reddish material and a hole in the surface of the pebax.Bwi became aware of a hole on the surface of the pebax on (b)(6) 2024 and have also assessed this returned condition as reportable.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on (b)(6) 2024, noted a correction the 3500a initial as in error did not include ¿device sensing problem (a0709)¿ in the h 6.Medical device problem code field.Therefore, processed.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18748014
• MDR Text Key: 335878200
• Report Number: 2029046-2024-00561
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

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 Catalogue Number: D134701
• Device Lot Number: 31173741L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/22/2024
• Supplement Dates FDA Received: 03/13/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT SHEATH; UNK GENERATOR