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

Model Number D128208

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976); Material Protrusion/Extrusion (2979)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.It was reported that the catheter would not go through the sheath after it was successfully introduced twice before.Upon inspection it appears one of the electrodes was damaged.It was replaced and case continued without incident.No patient consequences were reported.The insertion tool was used during the procedure.It appeared like something was exposed.The medical team was unsure as to whether the exposure resulted in any lifted or sharp rings.There was no partial or total detachment.Impeded device is not mdr-reportable.Electrode damaged without foreign material or sharp/rough edges is not mdr-reportable.Exposed internal components is mdr-reportable.

Manufacturer Narrative

On 26-jan-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.It was reported that the catheter would not go through the sheath after it was successfully introduced twice before.Upon inspection it appears one of the electrodes was damaged.It was replaced and case continued without incident.No patient consequences were reported.Device evaluation details: visual analysis revealed no damage or anomalies on the device; all the electrodes were found in good condition.A dimensional test was performed, and the outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal action related to the complaint was found during the review.The issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 19-jan-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal action related to the complaint was found during the review.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16208777
• MDR Text Key: 308302479
• Report Number: 2029046-2023-00128
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2023

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 Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30920762L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 01/19/2023; 01/26/2023
• Supplement Dates FDA Received: 01/19/2023; 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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