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

Catalog Number D132705

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified the hole on the pebax.Initially it was reported that the catheter temperature on the generator rose rapidly during ablation at 30w to 45 deg celsius.This happened on a few lesions, impedance and catheter position were stable throughout.Catheter cable replaced which did not resolve.Catheter checked visually and blood was noted within the catheter tip spring.New catheter resolved issue.The delay was 5 minutes.The procedure was completed successfully with no patient consequence.A video was provided.Additional information was received.The temperature cut off value was reached on several occasions (45 degrees celsius) which prevented further ablation.They do not recall the value of 45 degrees being exceeded.The system stopped/prevented ablation when the catheter temperature reached 45 degrees.The system did not ablate at or above 45 degrees.The generator was set to power control mode 30w, temperature cut off 45 degrees celsius, and power cut off 30w.The physician did not comment on any difficulty withdrawing or maneuvering the catheter.There did not appear to be any physical damage on the catheter; however, this is the first time the caller had noticed that blood had appeared to enter the catheter tip spring.A picture was provided.The temperature issue was assessed as non mdr reportable.Since the generator stopped delivering radio frequency (rf), the most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The blood noted in the catheter tip spring issue was assessed as non mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 04-jul-2023 there was reddish material observed in the pebax area; also, a hole was found.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 04-jul-2023.

Manufacturer Narrative

The investigation was completed on 04-jul-2023.A video and picture were received for evaluation following biosense webster's procedures.According to the video and picture provided by the customer, reddish material was observed inside the pebax; however, no external damages were observed on the pebax section.The picture and video do not provide sufficient information related to the temperature issue reported by the customer.The customer complaint was confirmed based on the picture and video received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis was performed and reddish material was observed in the pebax area; also a hole was found.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A cool flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The pebax issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The temperature issue reported by the customer could be related to the reddish material observed.The instructions for use contain the following recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.Flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.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 ¿temperature¿ issue and ¿blood noted in the catheter tip spring¿ issue.In addition, the biosense webster inc.Analysis findings of the ¿reddish material observed in the pebax area; also, a hole¿ issue.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 28-sep-2023, the product investigation was reopened to clarify/correct the investigation findings which resulted in the following changes/corrections.Added to the product investigation, ¿the potential cause of the damage on the pebax could be related to the procedure.¿ also added in h6.Investigation conclusions: unintended use error caused or contributed to event (d1102) therefore, corrected explanation of codes under 3500a initial "h10.Additional manufacturer narrative": -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.-investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿temperature¿ issue and ¿blood noted in the catheter tip spring¿ issue.In addition, the biosense webster inc.Analysis findings of the ¿reddish material observed in the pebax area; also, a hole¿ issue.

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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
• 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: 17445637
• MDR Text Key: 320253926
• Report Number: 2029046-2023-01681
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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: D132705
• Device Lot Number: 30821713M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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: NON BWI-ABBOTT FASTCATH SL1 8.5 FRENCH SHEATH; SMARTABLATE GENERATOR KIT-WW; UNKNOWN BRAND CATHETER; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE