MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL¿ MAPPING CATHETER WITH TRUEREF¿ TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D140901

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

Patient Problem Perforation of Vessels (2135)

Event Date 08/24/2022

Event Type  Injury  

Event Description

It was reported that an unknown female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter and an optrell¿ mapping catheter with trueref¿ technology.The optrell and soundstar became tangled and the patient suffered vascular injury requiring intervention.During a pvc case, the patient suffered a vascular injury.The bwi company representative stated the optrell catheter got entangled with the ice (intracardiac echocardiography) catheter.They were moving thru the atrium and the ice catheter went thru one of the optrell splines.They kept trying to pull the optrell catheter and eventually they pulled the sheath out that the optrell catheter was in.The proximal paddle then got entrapped with the shaft of the ice catheter.As they continued to pull the optrell, both the ice catheter and the sheath it was in, went out of the vein and into the tissue.The patient started bleeding from the large hole.A vascular surgeon was called and he told them to pull it all out of the skin.They pulled the optrell, the shaft of the ice catheter and the sheath out of the skin and then cut the optrell catheter and cut the ice catheter and they were able to remove everything.It was also noted that before the catheter was pulled, fluoroscopy was not used to look at the catheter.The fellow told the physician to look on fluoro before the catheter was pulled but they did not.The medical intervention provided was a purse stitch to stop the bleeding of the vein and pressure was held for a long time.The patient was reported to be in stable condition.Medical device entrapment with excessive manipulation required is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.This report is for the optrell¿ mapping catheter with trueref¿ technology.The report for the soundstar eco 8f ultrasound catheter is contained within manufacturer report number 2029046-2022-02235.

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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

Manufacturer Narrative

On 18-oct-2022, the product investigation was completed.It was reported that an unknown female patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter and an optrell¿ mapping catheter with trueref¿ technology.The optrell and soundstar became tangled and the patient suffered vascular injury requiring intervention.Device evaluation details: visual inspection testing was performed following bwi procedures, and the catheter tip was observed cut with internal parts exposed.According to the information provided, the cut was performed by the physician; " they pulled the optrell, the shaft of the ice catheter and the sheath out of the skin and then cut the optrell catheter and cut the ice catheter and they were able to remove everything." this issue could be related to the procedure.The rest of the catheter looks in good condition.A manufacturing record evaluation was performed for the finished device 30804913m number, and no internal actions related to the reported complaint condition were identified.The root cause of the adverse event remains unknown.No conditions were observed that could contribute to the adverse event.The instructions for use contain the following warnings and precautions; when using the catheter with conventional systems (such as fluoroscopy or ultrasound imaging), or with the carto¿ 3 system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement and placement should be done through a guiding sheath under direct imaging guidance.In addition, extra care should be taken while inserting, aspirating, and manipulating the guiding sheath.And prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy or ultrasound to confirm that the spine assembly is not entangled with another catheter or with an anatomical structure.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: OPTRELL¿ MAPPING CATHETER WITH TRUEREF¿ TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 15433555
• MDR Text Key: 300027359
• Report Number: 2029046-2022-02234
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211438
• 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: 11/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: D140901
• Device Catalogue Number: D140901
• Device Lot Number: 30804913M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female