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

Model Number R7F282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).The biosense webster, inc.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 85-year-old, male patient, born on (b)(6) underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a vessel perforation issue occurred.The patient¿s groin was punctured and a decanav electrophysiology catheter was introduced into the right groin sheath.The x-rays showed that the catheter had perforated through the femoral vein.The physician did not pull catheter back until the vascular surgeon had arrived and scrubbed in.Multiple x-rays were performed and decanav catheter eventually pulled back.It appeared that the decanav had gone through the false lumen.The case proceeded only as cavotricuspid isthmus (cti) and the pulmonary vein isolation (pvi) was not performed due to risk of bleeding from heparin.No consequences were noted during the rest of case.The procedure was delayed 40 minutes and was not successfully completed.The physician¿s opinion on the cause of this adverse event was a stiff catheter and patient age (patient condition related).The patient has recovered well.

Manufacturer Narrative

H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.Investigation findings: open circuit (c0205) /investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the biosensor error.The device evaluation was completed on 15-aug-2022.It was reported that an 85-year-old, male patient, born on 18-apr-1938 underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a vessel perforation issue occurred.The patient¿s groin was punctured and a decanav electrophysiology catheter was introduced into the right groin sheath.The x-rays showed that the catheter had perforated through the femoral vein.The physician did not pull catheter back until the vascular surgeon had arrived and scrubbed in.Multiple x-rays were performed and decanav catheter eventually pulled back.It appeared that the decanav had gone through the false lumen.The case proceeded only as cavotricuspid isthmus (cti) and the pulmonary vein isolation (pvi) was not performed due to risk of bleeding from heparin.No consequences were noted during the rest of case.The procedure was delayed 40 minutes and was not successfully completed.The physician¿s opinion on the cause of this adverse event was a stiff catheter and patient age (patient condition related).The patient has recovered well.Device evaluation details: according to pictures provided by customer, x-rays appeared that cs catheter had perforated through femoral vein.The root cause of the issue cannot be determined.Customer complaint was confirmed based on the picture received.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 that no damage nor anomalies were observed on the device.Per the event, several tests were performed.The electrical feature was tested, and no issues were observed.In addition, the product was deflecting correctly.Magnetic sensor functionality test was performed, and the device was recognized on the system; however, error 337 was displayed on the screen due to an open circuit on the tip area.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition 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.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14774470
• MDR Text Key: 295056074
• Report Number: 2029046-2022-01401
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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: 01/27/2023
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30718037M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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 Age: 85 YR
• Patient Sex: Male