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

Model Number D128211

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The first visual was performed and one spline appeared out of shape.A closer second inspection was performed and it was observed that a spline was out of shape and an electrode was lifted without polyurethane (pu) the on edge.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The root cause of the electrode damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the shipment, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Note: the event date was not provided; as such field b 3.Date of event has been left blank.Manufacturer's ref.# (b)(4).

Event Description

It was reported that 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 damage.It was initially reported by the customer that there was strong interference signals on electrode 7-8.The issue continued even after exchanging dongle and cable.There was no information on how the issue was resolved.There were no patient consequences.The customer¿s reported issue of interference on the electrode signals was assessed as not mdr reportable since the risk to the patient is low.On 6/4/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found one spline looks out of shape.This finding was assessed as not reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.On 6/17/2020, during a second visual inspection, one spline was found outs of shape, an electrode lifted without polyurethane (pu) on the edge.This finding of a lifted electrode ring was assessed as mdr reportable as a malfunction since the device integrity is not maintained.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 6/17/2020 and reassessed this complaint 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10263662
• MDR Text Key: 202105237
• Report Number: 2029046-2020-00864
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2020

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: 11/29/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30318901L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2019
• 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