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

Catalog Number D133604IL

Device Problem Insufficient Cooling (1130)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the thermocool® smart touch¿ electrophysiology catheter was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a hole in the pebax and the tip was bent.The temperature and impedance test was performed, and no temperature was displayed due to an open circuit on the tip area.The root cause of the damage could be related to the handling of the device but this cannot be conclusively determined.A manufacturing record evaluation was performed and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.Additionally, a picture was received for evaluation from the customer.The picture was also evaluated following biosense webster's procedures.According to the picture provided by the customer, no temperature issues were observed on the carto 3 screen.The customer complaint was not confirmed based on the picture received.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the hole in the pebax.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the bent tip.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the bent tip.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¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax tip.It was initially reported by the customer that during the operation, there is high temperature reading from the catheter when radiofrequency (rf) is being delivered.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information received indicated the system stopped ablation when temperature cut-off value was exceeded within <2seconds.The generator parameters were set to power control mode, 45¿, 40w.The custeorm¿s reported issue of high temperature and generator shut off is not considered to be an mdr reportable issue since the generator stopped delivering rf, the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 5-apr-2023, the bwi pal revealed that a visual inspection of the returned device found a hole in the pebax.This finding was reviewed and reassessed this as an mdr reportable malfunction.

Manufacturer Narrative

On 9-may-2023, additional information was received indicating the temperature was too high during the maximum saline ablation, and the problem was not resolved with the saline flushing the catheter, and there was no abnormality after replacing the catheter.Additionally, the e1.Initial reporter facility address was provided, as such, the information has been added to the appropriate fields in section e.E1.Initial reporter contact name of (b)(6) was provided, however, it was not clarified if this was the physician or a nurse.As such, field e3.Initial reporter occupation has been left blank.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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; 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: 16858239
• MDR Text Key: 314461438
• Report Number: 2029046-2023-00952
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30939505M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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: THMCL SMARTTOUCH,TC,D,C3,OBL