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 Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

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.(b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a pentaray nav high-density mapping eco catheter where clot formation occurred.There was an occlusion in the pentaray nav high-density mapping eco catheter flow and the pump was giving an alarm for the occlusion and high pressure.The physician took out the pentaray nav high-density mapping eco catheter and saw a blood clot that had formed in the opening of the pentaray nav high-density mapping eco catheter flow mouth.This happened almost immediately in the surgery and they had not started ablating.No consequence for the patient.The carto 3 system didn¿t present any error messages.The pump alarm went off for occlusion/high pressure.The physician saw that there was a blood clot in the pentaray nav high-density mapping eco catheter when he removed it from the patient.There was not char, only a blood clot and occlusion in the pentaray.It was not excessive.There were no temperature issues.The smartablate generator was in power control mode.Temp cut of 45 degrees cesius.The noted temperature was around 34 degrees.Impedance around 130 watts.The patient was anticoagulated.They gave a bolus of 5000 heparin in the beginning and try to keep the act >300 by giving heparin and monitor every 20 minutes.Normal flow rates was used.Normal heparinized saline was used.The issue of occlusion of irrigation has been assessed as not reportable since it is highly detectable by the physician and the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event has been assessed as mdr reportable for the clot formation.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a pentaray nav high-density mapping eco catheter where clot formation occurred.There was an occlusion in the pentaray nav high-density mapping eco catheter flow and the pump was giving an alarm for the occlusion and high pressure.The physician took out the pentaray nav high-density mapping eco catheter and saw a blood clot that had formed in the opening of the pentaray nav high-density mapping eco catheter flow mouth.This happened almost immediately in the surgery and they had not started ablating.No consequence for the patient.Device evaluation details: on (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.Upon receipt, the catheter was visually inspected, and it was found in normal conditions, no blood clot was observed.Then per the reported event, an irrigation test was performed, and the catheter failed.The catheter was dissected and it was found that the irrigation tubing was folded in tip area near the electrode #22.A manufacturing record evaluation was performed and no internal action related to the reported complaint were identified.The customer complaint regarding irrigation has been verified.The root cause of the irrigation tube folded cannot be determined.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: 10538709
• MDR Text Key: 215491345
• Report Number: 2029046-2020-01274
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30325993L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW