MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D134721IL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax.It was initially reported by the customer that during the operation, there was a problem with the force of the catheter.A second catheter was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported force issue is not considered to be an mdr reportable event as the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2022, the bwi pal revealed that a visual inspection of the returned device found foreign material inside the pebax and a hole in the pebax.The findings were reviewed and determined to be an mdr reportable malfunction since the integrity of the device was compromised.

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and functional test of the returned device.Visual analysis of the returned sample revealed foreign material inside the pebax of the thermocool® smart touch® sf uni-directional navigation catheter.The force sensor functionality test was performed, per bwi procedures.No force sensor issue was observed.During the force sensor functionality test, the device was displayed correctly.However, the foreign material inside the pebax could cause the force errors.The device was inspected under microscope at the pebax area and there was damage on the pebax, a hole, that caused the foreign material inside the pebax.The damage in the pebax could be related to excessive force or to the shipment process.It should be noted that device failure is multifactorial.The instructions for use contain the following precautions: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This medwatch report was initially submitted on 22-sep-2022.This report is being resubmitted as this report failed submission as a result of the electronic gateway.Please reference fda ticket csh-28330 for additional details.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15946811
• MDR Text Key: 308262024
• Report Number: 2029046-2022-02295
• Device Sequence Number: 1
• Product Code: LPB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2023
• Device Catalogue Number: D134721IL
• Device Lot Number: 30700834L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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
• Treatment: THMCL SMTCH SF UNID, TC, D, IL