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 Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a visual inspection was performed on the device and it was found in good condition.A second closer inspection was performed and several damages were on the splines and rings of the catheter which were observed without pu on the edge.The damages observed might be related to the efforts to disengage the catheter from the mechanical valve.There is no alleged product malfunction reported on the device during the procedure.There is evidence that catheter was manufactured in accordance with documented specification and procedures.The instructions for use states that pentaray devices should not be used in patients with prosthetic valves.It is also stated that careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.A manufacturing record evaluation was performed for the finished device 30325869l number, and no internal actions related to the reported complaint condition were identified.The customer complaint has been verified.Based on available information, the failure mode does not appear to be caused by any internal biosense webster, inc.Processes.The instructions for use states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.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 patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and the biosense webster, inc.Product analysis lab noted several damages on the splines and rings of the catheter which were observed without polyurethane (pu) on the edge.Initially, the pentaray nav high-density mapping eco catheter got stuck in the mechanical valve.Therefore, they pulled it out.The spline was deformed or extended.When the catheter was replaced.The issue resolved.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The description of the spline deformed/extended was assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The medical device entrapment described was assessed as not reportable.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 was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and noted on march 30, 2020 that there were several damages on the splines and rings of the catheter which were observed without polyurethane (pu) on the edge.The described returned condition was assessed as reportable.The awareness date for this reportable lab finding is march 30, 2020.

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9970501
• MDR Text Key: 201944973
• Report Number: 2029046-2020-00554
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30325869L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2019
• 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