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

Model Number D134804

Device Problem Entrapment of Device (1212)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

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.Additionally, the bwi product analysis lab also received a photograph of the complaint device.The photo analysis has not yet begun and will be completed, the results of which will also be included in a supplemental 3500a report.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 a patient underwent an svt (supraventricular tachycardia) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and when trying to remove the ablation catheter, the catheter became lodged in the iliac artery.Contrast was used to visualize the vessel.The catheter was cut to straighten the curve and to be able to be removed without further complications.No patient consequences were reported.Additional information: the catheter was not able to be maneuvered as it was stuck in place in the groin.The only time we detached the catheter is when it was cut.There was no patient consequence and to the best of the medical team's knowledge, the recovery was not affected by this occurrence.Ir and vascular came in to help and cut the catheter.The incident occurred during the case.Medical device entrapment with excessive manipulation is mdr-reportable.

Manufacturer Narrative

On 25-may-2023, the product investigation and photo analysis were completed.It was reported that a patient underwent an svt (supraventricular tachycardia) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and when trying to remove the ablation catheter, the catheter became lodged in the iliac artery.Contrast was used to visualize the vessel.The catheter was cut to straighten the curve and to be able to be removed without further complications.No patient consequences were reported.Device evaluation details: a x-ray picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, the photo does not provided sufficient information related to the stuck condition reported by the customer, and therefore no results can be obtained from it.The product was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that the catheter was cut and stuck inside the sheath.Evidence of excessive force was observed on the shaft and sheath.The cut was a doctor's decision to straighten the curve and to be able to remove it without further complications.The damage could be related to the use of a smaller f (french) than the one recommended by the ifu, and an excessive force used during the procedure.A manufacturing record evaluation was performed for the finished device number lot 30974902l and no internal actions related to the complaint were found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instruction for use (ifu) contains the following contraindication: do not use the catheter with a long sheath or short introducer <8.5f in order to avoid damage to the catheter shaft.In addition, the ifu contains the following warning and precautions: do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: 16947902
• MDR Text Key: 315419446
• Report Number: 2029046-2023-01062
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30974902L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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