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); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient ((b)(6) patient weight kg or pounds not noted) underwent an unknown ablation procedure with a pentaray nav high-density mapping eco catheter.The pentaray catheter got caught in a mechanical mitral valve and spline broke off and is in the patient¿s femoral artery.The pentaray catheter got caught in a mechanical mitral valve.The physician tried to release the pentaray from the valve by rotating the sheath clockwise, which did not work.The physician then applied moderate traction / pull to try and release it, when one of the pentaray splines broke off from the catheter and remained attached to the mechanical valve.Upon closer inspection of the retrieved pentaray catheter, it became evident that it was the plastic casing of one of the splines (with the electrodes remaining on it) that had completely detached and remained in the mechanical valve.The procedure was abandoned.The patient is currently fine and has experienced no adverse effects from the incident.The x ray today showed that the spline had detached from the mechanical mitral valve and the patient has had a ct scan of the head today to try and locate the spline.It was not found in the head.The patient will have further ct scans to try and locate the spline.Additional information stated that the pentaray spline is in the femoral artery of the patient.As there are no adverse effects as a result of this, the consultant has decided to leave it there and not try to retrieve it.Additional information: the physician¿s opinion on the cause of this adverse event: procedure.No intervention was provided.Patient outcome of the adverse event: fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event: not really, his extended stay was for other reasons (fluid overload, possible chest infection).The patient was under general anesthesia for 5 hours.A transseptal puncture performed prior to the case cancellation.The patient has not exhibited any neurological symptoms since the procedure was completed.Since the event is life threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, pictures of the complaint device were received by bwi.According to pictures provided by the customer, the tip was with the spline broken.A manufacturing record evaluation was performed for the finished device 30608874l number, and no internal actions related to the reported complaint condition were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 (b)(6) male patient ((b)(6) patient weight kg or pounds not noted) underwent an unknown ablation procedure with a pentaray nav high-density mapping eco catheter.The pentaray catheter got caught in a mechanical mitral valve and spline broke off and is in the patient¿s femoral artery.The pentaray catheter got caught in a mechanical mitral valve.The physician tried to release the pentaray from the valve by rotating the sheath clockwise, which did not work.The physician then applied moderate traction / pull to try and release it, when one of the pentaray splines broke off from the catheter and remained attached to the mechanical valve.Upon closer inspection of the retrieved pentaray catheter, it became evident that it was the plastic casing of one of the splines (with the electrodes remaining on it) that had completely detached and remained in the mechanical valve.The procedure was abandoned.The patient is currently fine and has experienced no adverse effects from the incident.The x ray today showed that the spline had detached from the mechanical mitral valve and the patient has had a ct scan of the head today to try and locate the spline.It was not found in the head.The patient will have further ct scans to try and locate the spline.Additional information stated that the pentaray spline is in the femoral artery of the patient.As there are no adverse effects as a result of this, the consultant has decided to leave it there and not try to retrieve it.Additional information: the physician¿s opinion on the cause of this adverse event: procedure.No intervention was provided.Patient outcome of the adverse event: fully recovered (no residual effects).The patient did not require extended hospitalization because of the adverse event: not really, his extended stay was for other reasons (fluid overload, possible chest infection).The patient was under general anesthesia for 5 hours.A transseptal puncture performed prior to the case cancellation.The patient has not exhibited any neurological symptoms since the procedure was completed.Since the event is life threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, pictures of the complaint device were received by bwi.According to pictures provided by the customer, the tip was with the spline broken.A manufacturing record evaluation was performed for the finished device 30608874l number, and no internal actions related to the reported complaint condition were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

On 23-nov-2021, bwi received additional information indicating that the patient's weight was reported in kg--not american pounds.The patient is 133.0 kg.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

On 7-jul-2022, the product investigation was updated.The update is as follows: the instructions for use (ifu) states that do not use pentaray¿ catheters in patients with prosthetic valves.A relative contraindication for cardiac catheter procedures is an active systemic infection.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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12858256
• MDR Text Key: 285929055
• Report Number: 2029046-2021-02034
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30608874L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 133 KG