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

Catalog Number D128211

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a pentaray nav high-density mapping eco catheter and during the procedure the wire was exposed on the deflection position.No adverse patient consequences were reported.

Manufacturer Narrative

Additional information was received on 8/11/2018 indicating the manufacture date: 1/10/2018 and expiration date: 1/09/2021.Corresponding fields of this report have been updated.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer ref no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a pentaray nav high-density mapping eco catheter and during the procedure the wire was exposed on the deflection position.No adverse patient consequences were reported.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.(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: 7749519
• MDR Text Key: 116070630
• Report Number: 2029046-2018-01913
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30003575L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2019
• Patient Sequence Number: 1