MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134702

Device Problems Contamination (1120); Material Puncture/Hole (1504)

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

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Note: for component code, "biological and chemical (g01) is a preferred code but will not pass mdr submission to fda.On 12/7/2020, the bwi product analysis lab identified a hole in the pebax.The product investigation was subsequently completed.Device evaluation details: upon receipt, the catheter was visually inspected and it was found reddish material inside the pebax due to external damage (a hole).It was also found reddish material near the handle.Also, the irrigation of the catheter was checked and no leakage issues were detected.Finally, a patency flow test was performed and all the holes were irrigating correctly.A manufacturing record evaluation was performed for the finished device 30405015m number, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the damage on pebax and the reddish material on handle cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The issue did not represent any patient consequence.

Event Description

A patient underwent an ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole in the pebax with reddish material near the handle.During the procedure, there was blood leaking from the thermocool® smart touch® sf uni-directional navigation catheter plunger mechanism, where the orange part meets the black part of the handle.The catheter was not replaced, and the procedure was continued using the same catheter.No patent consequences were reported.The amount of blood observed was minimal.No additional interventions were required.The blood leakage is not mdr-reportable as the blood loss was minimal.The hole in the pebax is an mdr-reportable issue.

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11086285
• MDR Text Key: 229527119
• Report Number: 2029046-2020-02005
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2021
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30405015M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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