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 Twisted/Bent (2981)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

There appears to have been deviations in the procedure and the recommended bwi instructions for use (ifu).Per pentaray nav high-density mapping eco catheter ifu: the usage of this catheter is contraindicated in patients with prosthetic valves.On 1/28/2021, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Event Description

It was reported that a female patient (b)(6) underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter that became entrapped in the patient¿s mechanical mitral valve.During the procedure one of the catheter splines became entangled in the patient¿s mechanical mitral valve.A sheath was advanced, and the catheter was manipulated and was able to be withdrawal from the patient¿s body.Upon catheter removal, one of the catheter splines was damaged but remained intact.No detachment was reported.No surgical intervention nor prolonged hospitalization were required.Patient had no injury and had fully recovered.Physician¿s opinion is that the issue occurred due to the patient having a mechanical valve.The reported damage to the catheter splines is considered not mdr reportable since no internal components, no detachment and no sharp/rough electrodes were observed, then the risk to the patient is remote.

Manufacturer Narrative

It was reported that a female patient (80kg) underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter that became entrapped in the patient¿s mechanical mitral valve.During the procedure one of the catheter splines became entangled in the patient¿s mechanical mitral valve.A sheath was advanced, and the catheter was manipulated and was able to be withdrawal from the patient¿s body.Upon catheter removal, one of the catheter splines was damaged but remained intact.No detachment was reported.No surgical intervention nor prolonged hospitalization were required.Patient had no injury and had fully recovered.Physician¿s opinion is that the issue occurred due to the patient having a mechanical valve.Device evaluation details: the device evaluation has been completed.The device was visually inspected, and it was found the spine #2 with elongation.The electrodes #6, #7 and #8 were damages.The electrodes damaged present the condition lifted and polyurethane (pu) border damage.The magnetic, deflection and irrigation test features were tested, and no issues were observed.The catheter failed the electrical test due to damage electrodes.A manufacturing record evaluation was performed for the finished device 30459258l number, and no internal action was found during the review.The customer complaint has been confirmed.The root cause of electrodes damages was procedure related since it is reported the catheter was used in a mechanical valve.Considering the instructions for use (ifu) recommendation indicates that this effect could occur when pentaray¿ catheters is used in patients with prosthetic valves.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11283467
• MDR Text Key: 266238716
• Report Number: 2029046-2021-00139
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30459258L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 80