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

Catalog Number D134722IL

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

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

Event Date 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: a video was received for evaluation following biosense webster's procedures.According to the video provided by the customer, the force value reaches the 74g, this could be considered a high force value; however, this cannot be conclusively determined.Additionally, the physical complaint device was also received.Visual analysis of the returned sample revealed reddish material on the thmcl smtch sf unid catheter.Microscope examination in the pebax area revelated that there is a hole in the pebax.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specifications and procedures.However, it could be related to the handling of the device during the procedure, but this cannot be conclusively determined.The event described force issue was unable to duplicate during the product investigation however, the blood inside the pebax area found could be related to the reported issue.A manufacturing record evaluation was performed for the finished device batch number 30897381l, and no internal actions were identified.It should be noted that product failure is multifactorial.Regarding the additional finding observed, the instruction for use contains the following information: 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.To ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified that there was a hole on the pebax.During the procedure, a force issue occurred with the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.Force issue is not mdr-reportable.Hole in the pebax is mdr-reportable.

• 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: 16741104
• MDR Text Key: 313362768
• Report Number: 2029046-2023-00815
• Device Sequence Number: 1
• Product Code: DYB
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2023
• Device Catalogue Number: D134722IL
• Device Lot Number: 30897381L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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