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 Device Contamination with Body Fluid (2317)

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

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter and a thrombus/clot issue occurred.It was reported that after 4 hours in a cardiac ablation procedure, a catheter clot was observed.The catheter was replaced, and the issue resolved.The procedure was successfully completed.No patient consequences were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.It is most likely that an irrigation issue with the pentaray nav high-density mapping eco catheter had occurred causing a blood clot to become attached to the catheter; however this was not confirmed.With the information available this event will be conservatively be assessed as a mdr reportable thrombus/clot.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 3/11/2021.The 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 reference number: (b)(4).

Manufacturer Narrative

Per the device evaluation completion on 3/31/2021, updated the ra awareness date from 3/11/2021 to 3/31/2021.It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter and a thrombus/clot issue occurred.It was reported that after 4 hours in a cardiac ablation procedure, a catheter clot was observed.The catheter was replaced, and the issue resolved.The procedure was successfully completed.No patient consequences were reported.The device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and irrigation test of the returned device.Visual analysis of the returned device revealed that no damage or anomalies were observed on the pentaray nav eco.Irrigation test was performed, in accordance with bwi procedures.The catheter failed the test since the irrigation tube was found folded inside the tip area.It should be noted that device failure is multifactorial.The instructions for use contain the following precautions; flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The investigation to determine the root cause for irrigation tube folded will be continue.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿clot¿ issue.Investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the investigation finding of irrigation tube folded.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11363887
• MDR Text Key: 233579219
• Report Number: 2029046-2021-00210
• 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,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30446495L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER