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

Model Number D128211

Device Problems Material Separation (1562); Material Twisted/Bent (2981)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that a spine was observed bent and stretched also, the rings #5 and #6 were observed missing.Ring #7 was observed separated and no pu was observed on the edge.The damage could have been forced by trying to insert them into the sheath.The unit was inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram of this device per its part number that indicates proper manufacturing in accordance with documented specifications and procedures.A manufacturing record evaluation was performed for the finished device [30544929l] number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions in the instructions for use: this catheter is recommended for use with an 8f guiding sheath as the distal spines may be damaged if used with a sheath that is not compatible and is recommended to collapse the spines together prior to insertion as well as to avoid bending the spines.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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 a bent and stretched spline.Additionally, rings #6 and #7 were missing.Ring #7 was separated and no pu was observed on the edge.The findings were identified on (b)(6) 2021.During the procedure, when the pentaray nav was inserted into the sheath a bent spline was noticed.The catheter was replaced and the procedure was completed without patient consequences.Exposed internal parts is mdr-reportable.

Manufacturer Narrative

On 20-jan-2022, the product investigation was complete.A patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab identified a bent and stretched spline.Additionally, rings #6 and #7 were missing.Ring #7 was separated and no pu was observed on the edge.The findings were identified on (b)(6) 2021.During the procedure, when the pentaray nav was inserted into the sheath a bent spline was noticed.The catheter was replaced and the procedure was completed without patient consequences.Device evaluation details: visual analysis of the returned sample revealed that a spine was observed bent and stretched.Additionally, the rings #5 and #6 were observed missing.Ring #7 was observed separated and no polyurethane was observed on the edge.The damage could have been forced by trying to insert them into the sheath.A manufacturing record evaluation was performed for the finished device [30544929l] number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.The instructions for use contain the following precautions in the instructions for use: this catheter is recommended for use with an 8f guiding sheath as the distal spines may be damaged if used with a sheath that is not compatible and is recommended to collapse the spines together prior to insertion as well as to avoid bending the spines.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: 12848415
• MDR Text Key: 286924584
• Report Number: 2029046-2021-02000
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2024
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30544929L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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
• Treatment: CARTO 3 SYSTEM; THERMOCOOL SMARTTOUCH