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

Catalog Number D133605IL

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981); Mechanical Jam (2983)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received a photograph of the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.It was reported that during the operation, the shaft on the catheter was bent there were no exposed wires.A second device was used to complete the operation.There was no adverse event reported on patient.The damage did not result in any lifted or sharp rings.After advancing retrogradely in the aorta and deflected for a big curve, it could not be relaxed and could not be removed.After several attempts for relaxing, it succeeded in removing the device at last.The catheter was not pre-shaped.Sheath information was a terumo 8f short sheath.Bent shaft is not mdr-reportable.Medical device entrapment not requiring excessive manipulation is not mdr-reportable.Stuck deflection is mdr-reportable.

Manufacturer Narrative

On 4-jan-2023, bwi received additional information regarding the event.The medical team found that the catheter was bent after deflection in the patient's body.When the catheter was suspended in the heart cavity, it was deflected to 90 degrees, which was displayed 180 degrees under the ray.No patient harms or consequences have been reported.On 11-jan-2023, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.However, a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the shaft of the catheter was observed with a bent condition, this condition is related to the customer complaint.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 1-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.It was reported that during the operation, the shaft on the catheter was bent there were no exposed wires.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: visual analysis revealed the shaft bent.Damage was found right before the curve.A deflection test was performed, and the curve was deflecting within specifications; the deflection did not get stuck.No deflection issues were observed.A dimensional test was performed, and outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device 30792566m number, and no internal actions related to the reported complaint condition were identified.  the deflection issue reported by the customer could be related to the damage observed in the investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Physical damage observed suggest that excessive force or manipulation was applied; however, this could not 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: pc-(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: 16078221
• MDR Text Key: 308231065
• Report Number: 2029046-2022-03260
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2023
• Device Catalogue Number: D133605IL
• Device Lot Number: 30792566M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/03/2023; 02/01/2023
• Supplement Dates FDA Received: 01/25/2023; 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• 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: TERUMO 8F SHORT SHEATH