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 Break (1069)

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

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

On 3/31/2021, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter which resulted with a broken/bent spline.It was reported that the pentaray nav high-density mapping eco catheter had a broken/ bent spline.The damage did not result in wires/internal components being exposed and the damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the pentaray nav high-density mapping eco catheter.The pentaray nav high-density mapping eco catheter was not pre-shaped.The pentaray nav high-density mapping eco catheter was replaced, and the issue resolved.

Manufacturer Narrative

It was reported that the pentaray nav high-density mapping eco catheter had a broken/ bent spline.The damage did not result in wires/internal components being exposed and the damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the pentaray nav high-density mapping eco catheter.The pentaray nav high-density mapping eco catheter was not pre-shaped.The pentaray nav high-density mapping eco catheter was replaced, and the issue resolved.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi then conducted visual inspection of the returned device.Visual analysis of the returned sample revealed that one of the splines is bent and rings crushed, however, the polyurethane (pu) is covering the electrodes properly, no lifted ring was observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described was confirmed, however, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 11624514
• MDR Text Key: 266108952
• Report Number: 2029046-2021-00524
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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: 11/30/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30484577L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 05/04/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF UNID, TC, D; UNK_CARTO VIZIGO SHEATH