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

Model Number D133601

Device Problems Positioning Problem (3009); Material Split, Cut or Torn (4008)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 1/16/2021.The device was completed on 2/26/2021.Upon receiving, the catheter was visually inspected and reddish material and a cut on the surface of the pebax sleeve and internal parts exposed were observed.Per the complaint, the catheter was tested for deflection and the catheter failed.The catheter was dissected and residues of polyurethane application was found at the t-bar anchored place which indicates a proper manufacturing assembly.Additionally, catheter deflection is verified several times before leaving the facilities.A manufacturing record evaluation was performed for the finished device, and no internal action related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the t bar slippage cannot be determined since there was evidence of proper manufacturing assembly.The root cause of the damage on the 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster, inc.Product analysis lab observed a cut on the pebax surface with internal components exposed.Initially it was reported that there was a defective deflection.The catheter was replaced and the procedure was completed successfully with no patient consequence.The deflection issue was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and on 2/23/2021 observed reddish material inside the pebax and a cut on the pebax surface.Internal components were exposed.The returned condition of the cut on the pebax with internal components exposed was assessed as mdr reportable.The awareness date for this reportable lab finding is 2/23/2021.

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11556130
• MDR Text Key: 266248913
• Report Number: 2029046-2021-00396
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30377597M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2021
• Date Manufacturer Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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