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

Model Number D132705

Device Problems Complete Blockage (1094); Insufficient Cooling (1130); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 08/09/2021

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 failure analysis of the returned device.Visual analysis of the returned thermocool® smart touch¿ bi-directional navigation catheter revealed that a reddish material was found inside the catheter and a hole n the pebax area with internal metals exposed.Upon product receipt, the decontamination site reported that char was observed at the tip of the catheter, however, char was not observed when the device was inspected in the lab.It might have been lost during the decontamination process.The root cause of the pebax damage cannot be related to the manufacturing process since there is evidence that the device was manufactured by documented specifications and procedures.It could be related to the handling of the device during the procedure.Per the event, a flow pump test was performed, and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.The catheter was tested on the generator and the temperature and impedance values were observed within specifications.A manufacturing record evaluation was performed and no internal action was found during the review.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.Based on the noted findings, the customer complaint was confirmed.The event's assignment of root cause remains inconclusive based on the information available from the review.However, there are clinical and procedural factors that may have contributed to the reported issues rather than the design or manufacture of the device as there is documented evident that specifications and procedures were followed during manufacturing of the device.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.Power delivery should be interrupted if the temperature increases to 40°c during rf application.The irrigation system must be rechecked before restarting the rf application.In the event of a generator cutoff (impedance or temperature), the catheter must be withdrawn and the tip electrode inspected before rf current is reapplied.(b)(4).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

A patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.It was initially reported by the customer that during the procedure, the tip electrode¿s temperature increased to the temp limit of 50 celsius.The irrigation was not effective.Water was visible under the elastic spring cover.There was no visible damage to the pebax.Catheter replacement solved the problem.There were no patient consequences.Additional information was later received indicating temperature did not exceed the cut of value; the ep shuttle sys 100w generator system stopped immediately when the cut off value was reached.The generator was set to power control mode at 35w, temperature cut off 49 c with the correct catheter settings selected.The catheter was removed, flushed and it was apparent that water was leaking inside spring, irrigation was abnormally low even when flushed.No error was given from pump.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.Error was discovered by continuous temperature cutoff.The customer¿s reported occlusion/no irrigation issue, high temperature are not mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The foreign material (water) inside the pebax (spring cover) is not considered to be an mdr reportable as there was no report of the integrity of the device being compromised.On 11-feb-2022, pal revealed that a visual inspection of the returned device found a reddish material and a hole in the pebax of the device and metals are exposed.These findings of a hole in the pebax with metals exposure is an mdr reportable malfunction since it is confirmed that the integrity of the device has been compromised.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13712971
• MDR Text Key: 290469428
• Report Number: 2029046-2022-00495
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2022

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: 04/27/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30551111M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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: EP SHUTTLE SYS 100W; THMCL SMRTTCH,BI,NAV,TC,D-F,C3; UNKNOWN PUMP