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); Detachment of Device or Device Component (2907)

Patient Problems Mitral Insufficiency (1963); Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

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.A manufacturing record evaluation was performed for the finished device 30175450l number, and no internal actions was found during the review.Manufacturer's reference #: (b)(4).

Event Description

It was reported that a patient underwent a left sided atrial flutter (l-afl) ablation procedure under general anesthesia on which pentaray nav high-density mapping eco catheters were used and a medical device entrapment occurred which led to mitral valve incompetence requiring no interventions.Mid the procedure, a pentaray nav high-density mapping eco catheter (30187305l) would not flush after being removed and was being reintroduced.The caller stated that they tried to flush will a syringe to the port and the catheter still would not flush.The catheter was replaced, and the issue was resolved.The procedure was continued.The pentaray nav high-density mapping eco catheter (30175450l) became entangled in a mechanical mitral valve.There was a lot of resistance, the shaft and 3 splines were removed from the patient¿s body; however, catheter insulation and 6 electrodes are still in the patient and the mechanical valve is only semi functional.Remainder of the procedure was aborted.The damage resulted in wires and/or braid exposed.The patient was reported in stable condition and additional intervention was being considered.Extended hospitalization was required, the patient was on hold for heart transplant list due to quitting cigarettes only 2 months ago.After this event the hospital waived that hold and get them onto the list.They plan to keep the patient in the hospital until a heart becomes available.Transseptal puncture was performed during the case.The sheath used was a st.Jude medical long agilis.Per instructions for use (ifu), the usage of the pentaray nav high-density mapping eco catheter is contradicted in patients with prosthetic valves.The issue of medical device entrapment-excessive manipulation required, and tip fully separated were assessed as reportable issues.The issue of mitral valve incompetence is considered serious and is mdr reportable.The biosense webster, inc.Product analysis lab received the device for evaluation on may 13, 2019 and it was returned in the condition reported.It was noted that on initial visual inspection that spline b was stripped, rings 5 & 6 are missing, spline c was stripped, all rings were missing, and internal wires were exposed.This returned condition remains assessed as reportable.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a left sided atrial flutter (l-afl) ablation procedure under general anesthesia on which pentaray nav high-density mapping eco catheters were used and a medical device entrapment occurred which led to mitral valve incompetence requiring no interventions.Mid the procedure, a pentaray nav high-density mapping eco catheter (30187305l) would not flush after being removed and was being reintroduced.The caller stated that they tried to flush will a syringe to the port and the catheter still would not flush.The catheter was replaced, and the issue was resolved.The procedure was continued.The pentaray nav high-density mapping eco catheter (30175450l) became entangled in a mechanical mitral valve.There was a lot of resistance, the shaft and 3 splines were removed from the patient¿s body; however, catheter insulation and 6 electrodes are still in the patient and the mechanical valve is only semi functional.Remainder of the procedure was aborted.The damage resulted in wires and/or braid exposed.The patient was reported in stable condition.The device was inspected, and spine b was observed stripped, rings 5 and 6 were observed missing, spine c was also stripped with all rings missing, internal parts were observed exposed.Then, during the second visual inspection electrode # 18 and 14 were observed smashed, however polyurethane (pu) margin was observed on the edge.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.Per instructions for use (ifu), the usage of the pentaray nav high-density mapping eco catheter is contradicted in patients with prosthetic valves.Damage to the valve and the possible need for surgical intervention are known complications of its use in mechanical valves.The root cause of the damage observed cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, this issue is related to the procedure.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Additional information was received on june 6, 2019 from medwatch mw5086781 and it was noted that the echocardiogram suggested that one of the leaflets of the mechanical valve may be in a fixed position and not moving.The study suggested mild prosthetic mitral regurgitation.The right heart catheterization suggested two catheter fragments entrapped within the mechanical valve with the involved leaflet in a closed position, the second leaflet was moving freely.Patient already received transplant.The patient was reported in stable condition and improving back to baseline health, plan for discharge home was for the following week.(b)(4).

Manufacturer Narrative

During an internal review of this event on (b)(6) 2020, it was discovered that the patient code 3165 "device fragments in patient" was inadvertently omitted from field h6.Patient code in the initial 3500a medwatch form.The code has now been added.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: 8637745
• MDR Text Key: 145990696
• Report Number: 2029046-2019-03165
• 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,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2019

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 Expiration Date: 01/24/2022
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30175450L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 06/25/2019; 06/04/2020
• Supplement Dates FDA Received: 06/27/2019; 07/19/2019; 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ST. JUDE MEDICAL LONG AGILIS SHEATH.; ST. JUDE MEDICAL LONG AGILIS SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability