MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, D, 2-6-2; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and the patient¿s tricuspid valve was damaged when removing the catheter.The catheter was entrapped in the sub septal tricuspid valve leaflet.The medical team attempted to retrieve it by anti-clocking the catheter which did not work.Eventually it came free by pulling the catheter and applying more force.The team looked at the intra-cardiac echo and observed tricuspid regurgitation as a result of this entrapment.The surgeon believed that they may have damaged the patient¿s tricuspid valve and caused tricuspid regurgitation.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; and it required surgical intervention to prevent a permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The medical device entrapment was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).

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.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

The device evaluation was completed on 02-sep-2022.It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter and the patient¿s tricuspid valve was damaged when removing the catheter.The catheter was entrapped in the sub septal tricuspid valve leaflet.The medical team attempted to retrieve it by anti-clocking the catheter which did not work.Eventually it came free by pulling the catheter and applying more force.The team looked at the intra-cardiac echo and observed tricuspid regurgitation as a result of this entrapment.The surgeon believed that they may have damaged the patient¿s tricuspid valve and caused tricuspid regurgitation.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis was performed on the returned sample.The only part that was returned was the portion of the catheter from the shaft to the tip.No issues were observed on the shaft and tip.The customer issue could not be evaluated since the device was cut and the handle was not returned.A manufacturing record evaluation was performed for the finished device 30751509l number, and no internal actions related to the reported complaint condition were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.The event described was not confirmed.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instructions for use contain the following warnings and precautions; do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.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

Additional information was received on 22-nov-2022.It was reported that the physician¿s opinion on the cause of this adverse event was that it was procedure related combined with known product-related issue as per ¿fsn.They attempted to position the pentaray in the right ventricular outflow tract (rvot) via right femoral access.First passage across tricuspid valve (tv) (through centre of tv as per intracardiac echocardiography (ice)) into basal right ventricle (rv) ok, then attempted to turn clockwise to rvot/ pulmonary valve area (pva), unable to turn.Tried that a few times then opposite direction but catheter entrapped with appearance of broomstick like in fsn.Appeared stuck in septal subvalvar apparatus.Counterclockwise rotation, steering no help (was through short sheath, attempted to position long sheath over catheter via cutting at shaft but not able to pass sheath at groin), catheter tip released under simple traction thereafter; all components removed from patient (catheter shaft and tip fully intact).Patient was well and continued with mapping/ablation with a thermocool smarttouch (stsf) catheter only.No clinical sequelae, but targeted echo next day found jet of mild late-systolic only triscuspid regurgitation (not visible on standard views.Patient well at follow up.Echo surveillance planned.Intervention provided was a manual catheter removal via counter rotation and simple traction.The patient fully recovered.Echo finding of mild tricuspid regurgitation possibly due to minimal disruption of some tricuspid valvar apparatus after catheter entrapment and removal.No additional patient treatment required.Will surveil at future echocardiography.The patient did not require extended hospitalization because of the adverse event.The patient was discharged the next day (day after ablation) as planned.The patient¿s age at the time of event was 45 years old, female, 67 kg in weight.Relevant tests/laboratory data- echo data (intra-op ice and post-op tte).Other relevant history-hypertension, treated with ramipril.The pentaray was not used in the mitral valve and the patient did not have a mechanical heart valve.Based on the additional information received, the following were updated: concomitant product section, a 2.Patient age at the time of event, a2.Age unit, a 3.Gender, a 4.Weight of the patient, a 4.Weight unit, b 6.Tests/lab data including date, b 7.Medical history/preexisting condition, e 1.Initial reporter title, e 1.Initial reporter first name, e 1.Initial reporter last name, e1.Initial reporter email, e 3.Initial reporter occupation, e 2.Health professional? g 2.Is report source health professional, e1.Initial reporter phone: (b)(6) 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 ECO 7FR, D, 2-6-2
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15090600
• MDR Text Key: 296466039
• Report Number: 2029046-2022-01691
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2022

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: 30751509L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/24/2022
• Supplement Dates Manufacturer Received: 08/04/2022; 09/02/2022; 11/22/2022
• Supplement Dates FDA Received: 08/30/2022; 09/30/2022; 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2022
• 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
• Treatment: UNK_SMART TOUCH BIDIRECTIONAL SF.
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 67 KG