MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133605IL

Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination /Decontamination Problem (2895)

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

Event Date 12/03/2022

Event Type  malfunction  

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified a hole on the pebax with reddish material inside.During the procudure, a force issue occurred on the catheter.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.In the catheter, there was blood infiltration at the spring of the force sensor.A second device was used to complete the operation.There was no adverse event reported on patient.Force issue is not mdr-reportable.Blood/foreign matter on external portions of the device is not mdr-reportable.Hole in the pebax is mdr-reportable.

Manufacturer Narrative

The product investigation was completed based on the photo analysis and evaluation of the physical device.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, blood was observed inside the pebax, no external damages were observed on the pebax, although there is no evidence of a force issue, the blood observed on the pebax could be related to the customer complaint at the procedure time; however, this cannot be conclusively determined.The physical device was also returned and evaluated.Visual inspection was performed and reddish material and a hole were observed in the pebax component.The force feature was tested on the carto and high force values were observed, this could be related to the reddish material inside the pebax component.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.  the reported issue by the customer was confirmed.The root cause of the hole on the pebax cannot be determined, it should be noted that the damage is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: in order 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.If additional information is received regarding this event, a supplemental (b)(4) report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 16503238
• MDR Text Key: 311145737
• Report Number: 2029046-2023-00494
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2023

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 Expiration Date: 06/22/2023
• Device Catalogue Number: D133605IL
• Device Lot Number: 30816358M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: APT MEDICAL SHEATH, FRENCH SIZE, 8.5F