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

Model Number D128208

Device Problems Entrapment of Device (1212); Separation Problem (4043)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30406011l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure and a medical device entrapment occurred which the spline covering separated.During the procedure while mapping around the patient¿s mechanical mitral valve with a pentaray nav high-density mapping eco catheter, one of the catheter splines got entrapped.The physician moved the catheter and immediately lost intracardiac signal from that spline.The catheter was withdrawn from the patient¿s body; however, one spline covering was missing.Fluoroscopy was used and it showed that the missing component did not move from that area.Patient was asymptomatic.The physician considered use a snare to entrap the missing component, but since the patient had mechanical valve, he decided to not perform any intervention.Surgery was also considered but there¿s no confirmation that it was done.Blood thinners were administered to the patient.Patient¿s condition unchanged.It is unknown if extended hospitalization was required.The physician attributed the causality of the event to product malfunction and patient¿s condition.The sheath used during the case was an abbott agilis small curve.Per pentaray nav high-density mapping eco catheter instructions for use, the usage of this product in patients with mechanical valve is contraindicated.The medical device entrapment and the separated spline covering were both assessed as mdr reportable issues.The signal issue was assessed as not mdr reportable.The patient's heart rhythm was still visible to the operator when signal noise or loss only affects only the body surface or intracardiac electrograms (but not both).

Manufacturer Narrative

Initially it was reported that a medical device entrapment occurred which the spline covering was separated.The bwi product analysis lab received the device for evaluation and observed on (b)(6)2020 that the device was returned in the condition reported as the catheter splines were detached from the tip with internal parts exposed.The spline covering issue remains assessed as mdr reportable.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).

Manufacturer Narrative

Device evaluation was completed on (b)(6) 2020.It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure.During the procedure while mapping around the patient¿s mechanical mitral valve with a pentaray nav high-density mapping eco catheter, one of the catheter splines got entrapped.The physician moved the catheter and immediately lost intracardiac signal from that spline.The catheter was withdrawn from the patient¿s body; however, one spline covering was missing.Fluoroscopy was used and it showed that the missing component did not move from that area.Patient was asymptomatic.The physician considered to use a snare to entrap the missing component, but since the patient had mechanical valve, he decided to not perform any intervention.Surgery was also considered but there¿s no confirmation that it was done.Blood thinners were administered to the patient.Patient¿s condition unchanged.It is unknown if extended hospitalization was required.The device was inspected, and it was found with a spline detached from the tip and internal parts were exposed.The test related with the event description was not possible to perform due to the returned condition of the device.A manufacturing record evaluation was performed for the finished device, and no internal action related to the complaint was found during the review.The customer complaint regarding bad/ partial ecg error cannot be evaluated due to the returned condition of the spline.The root cause of the damage on the spline is related with the handling during the procedure since the customer declares it.The instructions for use (ifu) states do not use pentaray¿ catheters in patients with prosthetic valves.A relative contraindication for cardiac catheter procedures is active systemic infection.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10503144
• MDR Text Key: 216629470
• Report Number: 2029046-2020-01191
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30406011L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI-ABBOTT AGILIS SMALL CURVE SHEATH