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 Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed the device was visually inspected and found 2 of the splines were found damaged.One spline had foreign material stuck between electrodes and a sample of the solid clear foreign material was received for testing.The 2nd spline had slight kink between the electrodes.Also all the electrodes on the same spline look a little squashed.The catheter was then connected to the carto 3 system and failed the test since the icon was observed spinning.The spinning icon is not a manufacturing related issue since all the results of the sensors are within product specification, the potential root cause of the failure can be related to the eeprom component.There is evidence that the eeprom was properly calibrated during the manufacturing process, therefore the failure is unlikely to be manufacturing related.A fourier transform infrared spectroscopy test (ftir) was performed on the foreign material sample and the results showed that foreign matter under ring is composed by polyurethane-base material.The spline cover component can be pinpointed as the source of origin.Eds (energy-dispersive x-ray spectroscopy) analysis exhibited the presence of chlorine (cl) and sodium (na) elements in crystalline foreign material, presumably residues from saline solution.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been verified.The root cause of spinning icon, the foreign material particles and spline damage cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.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 an ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab identified foreign material attached to the electrodes.It was initially reported by the customer that during mapping there some catheter visualization issues where in the pentaray nav high-density mapping eco catheter appeared to be move around like a dance.The issue was resolved by changing the catheter to another one.The procedure was completed.There were no patient consequences.The customer's reported visualization issue was assessed as not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 2/26/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found problems on the splines.Spline #1 had something is stuck to the spline between electrode 2 and 3.Spline #2 was slightly kinked between electrode 1, 2, and 3.All 5 electrodes on the same spline look a little squashed.The findings were reviewed and determined the issues ¿kinked/squashed¿ electrodes on spline #2 are not mdr reportable since there is no indication of sharp edges nor exposed components, as such, the risk to the patient is low.The foreign material found on spline #1 was assessed as an mdr reportable malfunction.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9881829
• MDR Text Key: 200823472
• Report Number: 2029046-2020-00445
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30298461L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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