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

Model Number D132705

Device Problem Positioning Problem (3009)

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

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.Device evaluation details: upon receipt, the catheter was visually inspected, and it was found with a hole on pebax with reddish-brown material inside and internal parts exposed.Then, the deflection test was performed, and the catheter failed.A failure analysis was performed, the catheter was dissected, and both t bars were found slid down causing the improper deflection conditions.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the t bars slippage cannot be determined.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 specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.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

A patient underwent a atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole in the pebax with reddish-brown material inside and internal parts exposed.During the procedure, the thermocool st catheter puller wire broke.The catheter was replaced and the case continued.However, the puller wire of the replacement catheter broke as well.The catheter was replaced for the second time and the issue resolved.Additionally, it was reported that a decanav catheter had a catheter sensor error displayed on the carto 3 system.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The case continued.The magnetic sensor error is not an mdr-reportable issue.The hole in the pebax is an mdr-reportable issue.

• Brand Name: THERMOCOOL SMART TOUCH BI-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: 10987423
• MDR Text Key: 247900736
• Report Number: 2029046-2020-01914
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30369197M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0056-2018
• Patient Sequence Number: 1