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

Model Number D134805

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

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

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2023.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment with excessive manipulation occurred which required surgical intervention.The ablation catheter doubled over itself while trying to remove from the short sheath causing the catheter to be stuck in the sheath.The physician unsuccessfully tried to manipulate the catheter within the sheath to remove it.Vascular surgery was consulted at the time of the call.Additional information was received.Sheath was short sheath, brand and model unknown, 8.5 fr.No detachment of any component.Catheter was never knotted.No exposure of any internal catheter components or sharp edges.The issue resolved by vascular surgeon as looped a wire around the tip to uncurl and advance the catheter from the other side access (left sided groin access).Event occurred during use of bwi product.Patient's outcome is a full recovery with no residual effects and no requirement of extended hospitalization.The patient required vascular surgery groin access.The physician¿s opinion on the cause of this adverse event was that it was a bwi product malfunction.The medical device entrapment with excessive manipulation required was assessed as a mdr reportable malfunction.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 25-jan-2023, the shaft has a bent and the fifth electrode was also observed lifted; no internal components were exposed,.The lifted electrode was assessed as mdr reportable.The awareness date for this reportable lab finding was 25-jan-2023.The investigation was completed on 25-jan-2023.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment with excessive manipulation occurred which required surgical intervention.The ablation catheter doubled over itself while trying to remove from the short sheath causing the catheter to be stuck in the sheath.The physician unsuccessfully tried to manipulate the catheter within the sheath to remove it.Vascular surgery was consulted at the time of the call.The issue resolved by vascular surgeon as looped a wire around the tip to uncurl and advance the catheter from the other side access (left sided groin access).Catheter was never knotted.No exposure of any internal catheter components or sharp edges.Patient's outcome is a full recovery with no residual effects and no requirement of extended hospitalization.An x-ray picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the catheter was observed apparently doubled over itself inside the inside the patient's body; however, this cannot be conclusively determined.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed the shaft has a bent and the fifth electrode was also observed lifted; no internal components are exposed, can be the result of excessive force.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.Investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported adverse event and medical device entrapment-no excessive manipulation required issues.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the biosense webster inc.Analysis finding of the bent shaft issue.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the biosense webster inc.Analysis finding of the electrode damage issue.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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16129198
• MDR Text Key: 306986242
• Report Number: 2029046-2023-00069
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30912313L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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: SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND 8.5 FR SHORT SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female