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

Catalog Number D133602

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab (pal) identified a crack on the surface of the pebax.Initially, it was reported that the catheter displayed hi force during different times of the procedure when the physician was not applying high force.Therefore, it was zeroed often and after a few times, it simply displayed ¿force sensor error¿ on the carto.When removing the catheter, the physician said the catheter had some discoloration, not charring but some discoloration in the tip.Action taken when event occurred was they replaced the cable and then replaced the catheter.The procedure was delayed by seven minutes.It was not known if the procedure was successfully completed.There were no patient consequences multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 20-sep-2023, a crack on the surface with reddish material inside the pebax was observed.This event was originally considered non-reportable, however, bwi became aware of the crack on the surface of the pebax on 20-sep-2023 and have assessed this returned condition as reportable.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on (b)(6) 2023.The device evaluation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual inspection was performed and a crack on the surface with reddish material inside the pebax was observed.The crack on the surface could be related with the manipulation of the device during the procedure; however, this can not be conclusively determined.The magnetic and force feature were tested and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed; however, the blood inside the pebax could be related to the force issue reported by the customer.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer were confirmed.The foreign material inside the pebax could be the related with the discoloration in the tip and the force issue reported by the customer.The instructions for use contain the following information that should be considered: 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.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 17958032
• MDR Text Key: 325955407
• Report Number: 2029046-2023-02353
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133602
• Device Lot Number: 31042983M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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
• Treatment: UNK CABLE.; UNK_CARTO 3.