MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7D282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 a ventricular tachycardia with a decanav electrophysiology catheter and experienced a vessel perforation which required surgical intervention and prolonged hospitalization.It was reported that although a trans-ao (aortic) approach was attempted for lv pvc (left ventricular premature ventricular contraction), the decanav did not move from ao to lv.Occlusion was suspected and the catheter was changed to the stsf, but there was no change.It was revealed that the catheter was in the false lumen, causing aortic dissection.Timing when complaints occurred was 1 hour and 30 minutes after the patient entered the room.The procedure was discontinued and proceeded to a surgical procedure.The physician's opinions on the relationship between the event and the product was that originally, 9fr sheath had been entered the false lumen at the time of puncture.From there, the decanav had been advanced.Since the physician did not push the catheter forcefully after feeling the clogging, advancing the catheter might have spread the dissection further.There were no abnormalities observed prior to and during use of the product.The patient has a medical history of left atrial appendage obstruction.Patient required extended hospitalization because of the adverse event.Force visualization features used was real time graph; dashboard; vector; visitag.Additional filter used with the visitag was fot.Tag index was used.The lot number of the soundstar eco ge 8f catheter is g9287245.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on the 3500a initial report # mwr-03032023-0001363135, it was inadvertently reported that no lot number was provided by the customer.However, a lot number was provided as shown on d4.Lot of the 3500a initial report.Therefore, a manufacturing record evaluation was performed for the finished device number lot 30966928m and no internal action related to the complaint was found during the review.

Manufacturer Narrative

Additional information was received on 30-mar-2023.It was reported that the patient outcome of the adverse event is improved.Ablation was not conducted.No steam pop occurred.The event occurred during the puncture phase.It is possible that a part had strayed into the false cavity due to damage caused by the sheath after puncture.An irrigated catheter was used in the event and the flow setting was low flow rate 2ml/min.High flow rate 8ml/min (-34w) 15ml/min(35w<).Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.A visitag module was used and the parameters for stability used were range; 3mm time; 3sec fot; 25% tag size2.The physician¿s name was provided.Therefore, section e.Initial reporter was updated.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: DECANAV ELECTROPHYSIOLOGY CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16576578
• MDR Text Key: 311656035
• Report Number: 2029046-2023-00580
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: R7D282CT
• Device Catalogue Number: R7D282CT
• Device Lot Number: 30966928M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 02/21/2023; 03/30/2023
• Supplement Dates FDA Received: 03/20/2023; 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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: SOUNDSTAR ECO GE 8F CATHETER; THMCL SMTCH SF BID, TC, D-D; UNK BRAND 9FR SHEATH; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 64 KG