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 Device Interaction Problem (4001)

Patient Problems Rupture (2208); Foreign Body In Patient (2687)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

(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).

Event Description

It was reported that an unknown patient had a ablation procedure for afib - persistent.The patient had a history a mechanical mitral valve.During the procedure, the pentaray nav high-density mapping eco catheter got stuck inside the valve twice and fragments were generated.The physician faced resistance only when the catheter was stuck into the mitral valve.The damage resulted in wires being exposed.The sheath used was slo, st jude medical.No patient consequences noticed to date.On follow up on 24-feb-2021 the reporter stated: the patient presents no adverse effect at the moment.Since the event is life-threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.This report is for the 1st of 2 reportable pentaray nav high-density mapping eco catheters.The other device was reported in manufacturer report number _________.

Manufacturer Narrative

On 4/5/2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.On 4/6/2021, bwi received additional information regarding the event.Fragments were left in the patient and it is unknown if those fragments are going to be removed.The "foreign body in patient" health impact code was added.The "entrapment of device" medical device problem code was also added.The usage of the pentaray catheter is contraindicated in patient¿s with mechanical valves per the instructions for use (ifu).This report is for the 1st of 2 reportable pentaray nav high-density mapping eco catheters.The other device was reported in manufacturer report number 2029046-2021-00262.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 product investigation was completed.It was reported that an unknown patient had a ablation procedure for afib - persistent.The patient had a history a mechanical mitral valve.During the procedure, the pentaray nav high-density mapping eco catheter got stuck inside the valve twice and fragments were generated.The physician faced resistance only when the catheter was stuck into the mitral valve.The damage resulted in wires being exposed.The sheath used was slo, st jude medical.No patient consequences noticed to date.On follow up on 24-feb-2021 the reporter stated: the patient presents no adverse effect at the moment.Device evaluation details: according to pictures provided by the customer (file: photo 01), it was observed that the distal side of the spine "c" was found detached and internal components are exposed in the tip area.Additionally, the physical complaint device was also analyzed.Visual analysis of the returned sample revealed that spline c of the pentaray nav eco was found detached and internal components were exposed in the tip area.All units are inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30496605l number, and no internal actions related to the reported complaint condition were identified.The root cause of spline detached could be related to use pentaray catheter in a patient with mechanical valve.The instructions for use contain the following statement: use of this catheter not be appropriate for use in patients with prosthetic valves.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: 11402823
• MDR Text Key: 238401951
• Report Number: 2029046-2021-00263
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30473142L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 04/06/2021
• Supplement Dates FDA Received: 04/09/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention