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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number pc (b)(4) has two reports: (1) mfr # for product code d128211 (pentaray nav high-density mapping eco catheter  lot 30439442l) (2) mfr # 2029046-2020-02008for product coded 128211 (pentaray nav high-density mapping eco catheter  lot 30439698l).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a pentaray nav high-density mapping eco catheter where thrombus was found on the catheter tip.During priming there was white turbidity observed in the tubing set.The issue was resolved by replacing the tubing set.This issue of turbidity on the tubing set is not mdr reportable since this has been determined to be a cosmetic topic and not an actual film that can be detached from the inner wall and therefore cause any risk to the patient.After using the pentaray nav high-density mapping eco catheter for 4 hours, there was a thrombus in the lumen and it could not be flush.The issue was resolved by changing the pentaray nav high-density mapping eco catheter to another one.There were no patient consequences.It was also reported there was a suspected perforation of the left ventricle.It was reported there was a possibility that the rf needle of another company perforated the left ventricle.Only the soundstar catheter was in cardiac cavity at the time of the suspected perforation.There were no clinical symptoms of perforation of the heart and no medical treatment.The case was completed without any abnormality and the patient left the room.There is no confirmation of an actual perforation or that it was caused by any bwi product.As such, this will not be reported as an adverse event.The customer reported two (2) pentaray nav high-density mapping eco catheters with different lot numbers and with no indication as to which one had the thrombus on the tip.As such, the thrombus issue will be reported against both devices.

Manufacturer Narrative

On 1/13/2021, 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.#(b)(4).

Manufacturer Narrative

On 2/3/2021, additional information was received indicating the patient was a 77-year-old-male.The patient has fully recovered.There was no intervention provided.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a 77-year-old-male patient underwent cardiac ablation procedure with a pentaray nav high-density mapping eco catheter where thrombus was found on the catheter tip.After using the pentaray nav high-density mapping eco catheter for 4 hours, there was a thrombus in the lumen and it could not be flush.The issue was resolved by changing the pentaray nav high-density mapping eco catheter to another one.There were no patient consequences.Device evaluation details: the device was returned to biosense webster for evaluation and the evaluation has been completed.Bwi conducted visual inspection and irrigation test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the pentaray nav high-density mapping eco catheter.Irrigation testing was performed in accordance with bwi procedures.The catheter failed the test since the irrigation tube was found folded in tip area and white crystalized material was observed inside the irrigation tube.A sem (scanning electron microscopy) analysis was performed on the foreign material found inside irrigation tube.Energy dispersive spectroscopy (eds) analysis was performed on this section finding the following elements: na, cl, and c.Due the information shown on the eds analysis, is can be concluded that the particle is primarily composed of na and cl, presumably residues of saline solution.It should be noted that product 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.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 thrombus issue.Investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the occluded irrigation tube.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: 11092213
• MDR Text Key: 246073629
• Report Number: 2029046-2020-02007
• 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,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30439442L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK; DEF,6F,20P,ATRIAL,CC,2-10-2MM,; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE IRR TUBE SET; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Age: 77 YR