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

Catalog Number D133605IL

Device Problem Temperature Problem (3022)

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

Event Date 09/08/2021

Event Type  malfunction  

Event Description

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 cut on the pebax.It was initially reported by the customer that during the afib operation, there is no temperature displayed on the carto 3 system or generator.A second catheter was used to complete the operation.There was no patient consequence.The customer reported no temperature issue is not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event is remote.On (b)(6) 2021, the catheter was inspected by the bwi pal and found a cut on pebax and internal parts exposed.This finding was assessed as mdr reportable malfunction since the integrity of the device is compromised.

Manufacturer Narrative

Device investigation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and generator test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch¿ electrophysiology catheter.Visual analysis of the returned sample revealed a cut on the pebax and internal parts were exposed; however, the cut could be related with the handling of the device since in the manufacturing process there are control inspection points to avoid this type of issues.Generator test was performed in accordance with bwi procedures.The catheter failed the test since the catheter was not showing temperature values when it was connected to generator.Therefore, the catheter was dissected from tip.It was determined that there is a loss of electrical resistance from the cut to the dome creating the temperature issue.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The evaluation determined that the cause of no temperature cannot stablished.The instructions for use contain the following recommendations: if the rf generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.If temperature still is not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.Additionally, the customer provided pictures of the complaint issue showing that no temperature was observed on the generator screen.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint conditions were identified.Customer complaint was also confirmed based on the picture received.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13040401
• MDR Text Key: 288368764
• Report Number: 2029046-2021-02216
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2021

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: 06/23/2022
• Device Catalogue Number: D133605IL
• Device Lot Number: 30585932M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN GENERATOR