MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Entrapment of Device (1212); Material Separation (1562); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 28-mar-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 atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.The patient had a foreign body requiring prolonged hospitalization.In addition, medical device entrapment with excessive manipulation required, internal components exposed, and catheter shaft detached broken inside the patient issues occurred.It was reported that the physician mentioned to the bwi representative that the patient has a mechanical mitral valve to which the bwi representative informed the physician that the use of the pentaray nav high-density mapping eco catheter is contra-indicated for these patients.The physician acknowledged and chose to proceed with the case using the pentaray nav high-density mapping eco catheter.The physician was mapping the anterior wall of the left atrium when he noticed that the pentaray nav high-density mapping eco catheter was not moving and was likely stuck in the discs of the mechanical valve.In an attempt to free the catheter, the physician noted that the spline had been stripped of its soft polymer coating and electrodes.The fragments of the pentaray nav high-density mapping eco catheter spline (soft polymer and electrodes) were seen lodged in one of the valve discs, where one of the valve discs was being held open with the catheter fragments while the other one was functioning.This was confirmed using fluoroscopy and intracardiac echocardiography (ice).The vitals were monitored throughout the event and they remained stable the entire time.The caller stated that they "did not provide medical intervention"; however, the cardiac surgeon came into the room "had a discussion with the physician" and the patient was removed from the room while still intubated.They stated it is unknown to them whether or not the patient required surgery for this issue.Additional information was received.The damage resulted in wires and/or braid being exposed, unknown if it resulted in any lifted or sharp rings.Unknown if there was a resistance or difficulty during insertion or removal of the device.The detachment was partial, one spline broke off.Physician left the fragment lodged in the mechanical valve.Picture provided.Physician¿s opinion on the cause of this adverse event was that it was procedure related.No intervention was provided.Outcome of the adverse event was unknown.Patient required extended hospitalization because of the adverse event because they wanted to monitor the location of the detached device and how the patient is doing.The event was assessed as mdr reportable for a patient consequence of ¿foreign body¿.Since the event was 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 was to be considered serious.The event was also assessed as mdr reportable for medical device entrapment with excessive manipulation required, internal components exposed, and catheter shaft detached broken inside the patient issues.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.It was reported that the physician mentioned to the bwi representative that the patient has a mechanical mitral valve to which the bwi representative informed the physician that the use of the pentaray nav high-density mapping eco catheter is contra-indicated for these patients.The physician acknowledged and chose to proceed with the case using the pentaray nav high-density mapping eco catheter.The physician was mapping the anterior wall of the left atrium when he noticed that the pentaray nav high-density mapping eco catheter was not moving and was likely stuck in the discs of the mechanical valve.In an attempt to free the catheter, the physician noted that the spline had been stripped of its soft polymer coating and electrodes.The fragments of the pentaray nav high-density mapping eco catheter spline (soft polymer and electrodes) were seen lodged in one of the valve discs, where one of the valve discs was being held open with the catheter fragments while the other one was functioning.This was confirmed using fluoroscopy and intracardiac echocardiography (ice).The vitals were monitored throughout the event and they remained stable the entire time.The caller stated that they "did not provide medical intervention"; however, the cardiac surgeon came into the room "had a discussion with the physician" and the patient was removed from the room while still intubated.They stated it is unknown to them whether or not the patient required surgery for this issue.Additional information was received.The damage resulted in wires and/or braid being exposed, unknown if it resulted in any lifted or sharp rings.Unknown if there was a resistance or difficulty during insertion or removal of the device.The detachment was partial, one spline broke off.Physician left the fragment lodged in the mechanical valve.Physician¿s opinion on the cause of this adverse event was that it was procedure related.No intervention was provided.Outcome of the adverse event was unknown.Patient required extended hospitalization because of the adverse event because they wanted to monitor the location of the detached device and how the patient is doing.The investigation was completed on 05-may-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, one spline was observed detached from the tip leaving internal components exposed.No conditions that might have contributed to the reported event were found.The root cause of the adverse event could be related to the usage of the device with a patient with mechanical mitral valve.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 of all features was performed following bwi procedures.Visual inspection was performed, and one spline was observed detached from the tip leaving internal components exposed.No conditions that might have contributed to the reported event were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The customer complaint was confirmed, the root cause of the adverse event could be related to the usage of the device with a patient with mechanical mitral valve.The instructions for use (ifu) contain the following contraindications: do not use the pentaray® catheters in patients with prosthetic valves.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: appropriate term/code not available (c22)/ investigation conclusions: cause traced to user (d11) were selected as related to the picture provided.-investigation findings: mechanical problem identified (c07) / investigation conclusions: failure to follow instructions (d1101) / component code: tip (g04129) were selected as related to the customer¿s reported medical device entrapment with excessive manipulation required, internal components exposed, catheter shaft detached broken inside the patient and adverse event issues.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: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 16675415
• MDR Text Key: 312627763
• Report Number: 2029046-2023-00712
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30936336L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/05/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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): Hospitalization
• Patient Sex: Female