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 Break (1069); Entrapment of Device (1212); Material Protrusion/Extrusion (2979)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2021

Event Type  Injury  

Event Description

It was reported that a female patient underwent an atrial tachycardia (at) ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment with excessive manipulation was required, internal components exposed and a broken tip issues occurred which resulted in a foreign body issue which required surgical intervention.The pentaray nav sh¿s b-spline in the cardiac cavity was separated between the fourth pole and the fluoroscopic marker when it was stuck in the mitral valve mechanical valve and, at that moment, pentaray was strongly drawn into the sheath and left in the cardiac cavity.After that, it seemed that the spline might have flowed from the left ventricle to the aorta, and it was confirmed on fluoroscopy that the detached spline remained in the descending aorta, and its position was also confirmed by transesophageal echo.A snare was inserted through the left inguinal artery, and the spline was removed from the patient¿s body.The part from the fourth electrode to the tip could be removed from the patient¿s body, but the fluoroscopic marker could not be retrieved and might have remained in the patient's body.Nitinol and copper wire inside the spline did not separate.This occurred 3 hours after start of use, and at mapping of left atrium.The procedure was completed by inserting a snare through the inguinal artery, and the remaining spline in the patient's body was removed from the patient¿s body.The patient is recovering/resolving.The patient had no abnormality at the time of lapse 4 hours after discharge.Seriousness: non-serious (moderate/minimal).It was reported that the physician commented that "we understand that the use of this product in the procedure with prosthetic valves is contraindicated.We have also heard of presentations related to mechanical valves related to pentaray at academic conferences, etc.For fluoroscopic markers whose recovery has not been confirmed, it is impossible to say anything because it may have been lost inside or outside the sheath, but it is important information, so the information should be kept in the medical record.The patient had no particular abnormality at the moment 4 hours after discharge." no abnormalities were observed before or during use of the products.The adverse event was assessed as mdr reportable.Since it is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.In addition, the event was assessed as mdr reportable for the malfunctions of medical device entrapment with excessive manipulation required, internal components exposed and a broken tip.

Manufacturer Narrative

Initial reporter phone: (b)(6).Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.The photograph investigation was completed on (b)(6) 2021.According to pictures provided by the customer, one of the pentarays' spline was detached with wires exposed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.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

Initial reporter phone: (b)(6).Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.The photograph investigation was completed on (b)(6) 2021.According to pictures provided by the customer, one of the pentarays' spline was detached with wires exposed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.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 tachycardia (at) ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment with excessive manipulation was required, internal components exposed and a broken tip issues occurred which resulted in a foreign body issue which required surgical intervention.The pentaray nav sh¿s b-spline in the cardiac cavity was separated between the fourth pole and the fluoroscopic marker when it was stuck in the mitral valve mechanical valve and, at that moment, pentaray was strongly drawn into the sheath and left in the cardiac cavity.After that, it seemed that the spline might have flowed from the left ventricle to the aorta, and it was confirmed on fluoroscopy that the detached spline remained in the descending aorta, and its position was also confirmed by transesophageal echo.A snare was inserted through the left inguinal artery, and the spline was removed from the patient¿s body.The part from the fourth electrode to the tip could be removed from the patient¿s body, but the fluoroscopic marker could not be retrieved and might have remained in the patient's body.Nitinol and copper wire inside the spline did not separate.This occurred 3 hours after start of use, and at mapping of left atrium.The procedure was completed by inserting a snare through the inguinal artery, and the remaining spline in the patient's body was removed from the patient¿s body.The patient is recovering/resolving.The patient had no abnormality at the time of lapse 4 hours after discharge.Seriousness: non-serious (moderate/minimal).It was reported that the physician commented that "we understand that the use of this product in the procedure with prosthetic valves is contraindicated.We have also heard of presentations related to mechanical valves related to pentaray at academic conferences, etc.For fluoroscopic markers whose recovery has not been confirmed, it is impossible to say anything because it may have been lost inside or outside the sheath, but it is important information, so the information should be kept in the medical record.The patient had no particular abnormality at the moment 4 hours after discharge." no abnormalities were observed before or during use of the products.The adverse event was assessed as mdr reportable.Since it is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.In addition, the event was assessed as mdr reportable for the malfunctions of medical device entrapment with excessive manipulation required, internal components exposed and a broken tip.

Manufacturer Narrative

Additional information was received on 13-dec-2021.The physician did not comment if the knob/piston were unable to be turned and/or pushed up and down.There was difficulty experienced while maneuvering the catheter or during the withdrawal.The bwi product analysis lab received the device for evaluation 04-jan-2022.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

It was reported that a female patient underwent an atrial tachycardia (at) ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment with excessive manipulation was required, internal components exposed and a broken tip issues occurred which resulted in a foreign body issue which required surgical intervention.The pentaray nav sh¿s b-spline in the cardiac cavity was separated between the fourth pole and the fluoroscopic marker when it was stuck in the mitral valve mechanical valve and, at that moment, pentaray was strongly drawn into the sheath and left in the cardiac cavity.After that, it seemed that the spline might have flowed from the left ventricle to the aorta, and it was confirmed on fluoroscopy that the detached spline remained in the descending aorta, and its position was also confirmed by transesophageal echo.A snare was inserted through the left inguinal artery, and the spline was removed from the patient¿s body.The part from the fourth electrode to the tip could be removed from the patient¿s body, but the fluoroscopic marker could not be retrieved and might have remained in the patient's body.Nitinol and copper wire inside the spline did not separate.This occurred 3 hours after start of use, and at mapping of left atrium.The procedure was completed by inserting a snare through the inguinal artery, and the remaining spline in the patient's body was removed from the patient¿s body.The patient is recovering/resolving.The patient had no abnormality at the time of lapse 4 hours after discharge.The device evaluation was completed on (b)(6) 2022.The device was returned to biosense webster for evaluation.A visual inspection, of the returned device, was performed in accordance with bwi procedures.Visual analysis of the returned pentaray nav eco device revealed that the b spline of the device was separated from the tip.The root cause of the adverse event and damage observed in the device based on the event information was related to a failure to comply with the contraindications of this device contained in the instructions for use.A manufacturing record evaluation was performed for the finished device 30631863l, and no internal action was found during the review.It should be noted that product failure is multifactorial.The instructions for use contain the following contraindication: do not use pentaray¿catheters in patients with prosthetic valves.A relative contraindication for cardiac catheter procedures is active systemic infection.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12930998
• MDR Text Key: 285247965
• Report Number: 2029046-2021-02104
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• 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: 30631863L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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: UNKNOWN BRAND SHEATH.; UNKNOWN BRAND SNARE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female