MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128208

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected, and it was found with splines and some rings bent and lifted; however, polyurethane (pu) around of the bent rings was observed.This issue could be related with the handling of the device during the procedure since in the manufacturing process there are control inspection points to avoid this kind of issues.A manufacturing record evaluation was performed for the finished device, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed.The root cause of the damage on electrodes could be related with the handling during the procedure.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 active systemic infection.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Event Description

A patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab identified electrode rings on the returned complaint device are bent and lifted.It was initially reported by the customer that the pentaray nav high-density mapping eco catheter became entangled in the mechanical valve of the patient.The catheter was able to be extracted without injury to the patient or the valve.Catheter was removed intact; the procedure completed.There were no patient consequences.Additional information received indicated there was no difficulty was experienced while maneuvering the catheter during the procedure.There was some resistance when trying to withdraw it from the mechanical valve but once it was released, the catheter was withdrawn successfully.The customer did not report any sharp edges, no detachments, and the tip was not knotted and no medical or surgical intervention was not required to release the device.A argon 8.5 french sheath was used during the procedure.With the information available, the initial event was reported as not reportable since the device was removed without surgical intervention, or without using a different device, the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 10/9/2020, the bwi product analysis lab received the complaint device for evaluation.On 11/11/2020, during product evaluation it was found electrode rings were damaged as they were found bent and lifted.These findings are considered to be mdr reportable malfunctions.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on 11/11/2020 and reassessed it as mdr reportable.

• 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
• 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: 10964258
• MDR Text Key: 228035793
• Report Number: 2029046-2020-01895
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30403540L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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