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); Sharp Edges (4013)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The bwi 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.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 ((b)(6)) underwent cardiac ablation procedure for atrial fibrillation (afib) with pentaray nav high-density mapping eco catheter and suffered device entrapment and component embolization requiring surgical intervention.It was reported that during a redo afib case, a mechanical mitral valve sheared a pentaray spline.The distal portion of the sheared spline was stuck in the left ventricle and the proximal two electrodes from the same spline were sheared and found in the carotid artery.This occurred at the end of the procedure after all ablation had already been completed.They were in the process of creating a post voltage map of the left atrium.The medical intervention provided was to attempt to snare the piece that was in the left ventricle but was unsuccessful.The patient is being monitored by ecg and put on a defibrillator.They plan on monitoring the patient overnight and tomorrow will be taken to surgery if needed.The caller did not state that there was any patient injury and the patient was in stable condition.The caller stated there were numerous conversations with the physician that there was a contraindication using the pentaray this way but continued with the procedure anyway.The caller stated that what is left of the catheter, is available to return.The physician¿s opinion is that the cause of the event was patient condition/mechanical valve.An attempt to snare the devices was unsuccessful patient was required to go to ct surgery to have foreign body removed.The final outcome is unknown.Patient needed to be observed and due to the required open heart surgery extended stay was required.As of (b)(6) 2020, the patient was still in the hospital.The sheath that was used was agilis.There was resistance while introducing or retracting the catheter from the sheath.The insertion tool was used during the procedure.The damage resulted in wires being exposed and sharp rings.The code ¿foreign body¿ is used to reflect the device embolization.Per the device instructions for use, the use of the pentaray nav high-density mapping eco catheter in patients with prosthetic valves is contraindicated.Since this required surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it was assessed as mdr reportable.The medical device entrapment, separation of the tip and electrode damage were assessed as mdr reportable malfunctions.

Manufacturer Narrative

Initially it was reported that there was damage to the pentaray nav high-density mapping eco catheter as the distal portion of the spline was sheared and the proximal two electrodes from the same spline were sheared.The damage resulted in wires being exposed and sharp rings.The biosense webster, inc.Product analysis lab observed on 11/6/2020 that the catheter was returned in the condition reported as the spline was detached from the tip with internal parts exposed and the proximal two electrodes from the same spline were detached.The returned condition remains assessed as mdr reportable 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).

Manufacturer Narrative

Device summary was completed on 12/9/2020.It was reported that a female patient (62 year old, inr 3.5, 250lb) underwent cardiac ablation procedure for atrial fibrillation (afib) with pentaray nav high-density mapping eco catheter and suffered device entrapment and component embolization requiring surgical intervention.It was reported that during a redo afib case, a mechanical mitral valve sheared a pentaray spline.The distal portion of the sheared spline was stuck in the left ventricle and the proximal two electrodes from the same spline were sheared and found in the carotid artery.This occurred at the end of the procedure after all ablation had already been completed.They were in the process of creating a post voltage map of the left atrium.The medical intervention provided was to attempt to snare the piece that was in the left ventricle but was unsuccessful.The patient is being monitored by ecg and put on a defibrillator.They plan on monitoring the patient overnight and tomorrow will be taken to surgery if needed.The caller did not state that there was any patient injury and the patient was in stable condition.The caller stated there were numerous conversations with the physician that there was a contraindication using the pentaray this way but continued with the procedure anyway.The caller stated that what is left of the catheter, is available to return.An attempt to snare the devices was unsuccessful patient was required to go to ct surgery to have foreign body removed.The final outcome is unknown.Patient needed to be observed and due to the required open heart surgery extended stay was required.As of (b)(6) 2020, the patient was still in the hospital.The sheath that was used was agilis.There was resistance while introducing or retracting the catheter from the sheath.The insertion tool was used during the procedure.The damage resulted in wires being exposed and sharp rings.The device was inspected, and it was found with a spline detached from the tip, internal parts exposed and the proximal two electrodes from the same spline were detached.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 spline broken and electrodes detached were confirmed.The root cause of the damage on the spline is related with the patient condition/mechanical valve as stated by the physician opinion.The instructions for use states that 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 the manufacturing record evaluation 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: 10814910
• MDR Text Key: 215489909
• Report Number: 2029046-2020-01656
• 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: 10/13/2020

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: 08/19/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30431332L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/06/2020; 12/09/2020
• Supplement Dates FDA Received: 12/04/2020; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI- AGILIS SHEATH; NON BWI- AGILIS SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR