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

Model Number R7F282CT

Device Problem Mechanical Jam (2983)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.The picture was received on 19-sep-2022.The investigation was completed on (b)(6) 2022.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, no damages or anomalies were observed on the device, the curvature noted on the tip of the device could be related to the stuck condition reported by the customer, however, this cannot be conclusively determined at this time.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was not confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a decanav electrophysiology catheter and a deflection stuck issue occurred.The decanav electrophysiology catheter was unable to be placed into the coronary sinus.When the catheter was removed from the body, it was noted that the catheter was stuck in deflected mode.The deflection plunger was not able to be moved.The catheter was replaced with a webster coronary sinus catheter to continue the procedure.There was no patient consequence reported.Additional information was received.The curve of the catheter was stuck in the deflected position.The knob was not jammed.The failure was found during use.No external damage was noticed.The sheath used was a 7fr., company unknown.The event was assessed as mdr reportable for a deflection stuck issue.

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a decanav electrophysiology catheter and a deflection stuck issue occurred.The device evaluation was completed on 17-aug-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and deflection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Deflection testing was performed and the deflection mechanism failed.The catheter was not able to deflect and relax.The deflection mechanism was stuck.The curve was in a deflected position.A manufacturing investigation was performed and it was identified that this issue is related to the manufacturing process since the deflection mechanism was incorrectly assembled.Therefore, an awareness training was performed to prevent similar events.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to manufacturing (d03) / component code: anchor (g04005) were selected as related to the customer¿s reported ¿deflection stuck¿ issue.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: anchor (g04005) were selected as related to the customer¿s reported ¿deflection stuck¿ 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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 24-jun-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.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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15601717
• MDR Text Key: 307267826
• Report Number: 2029046-2022-02513
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30840859M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 06/24/2023; 08/17/2023
• Supplement Dates FDA Received: 07/20/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• 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
• Treatment: UNKNOWN BRAND SHEATH 7FR.; WEBSTER CORONARY SINUS CATHETER.