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

Catalog Number	D128207
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.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.On 3/28/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a penta ray nav high-density mapping eco catheter and the biosense webster inc.(bwi) product analysis lab (pal) observed damaged electrodes and rings on spine c.Initially it was reported that a noise issue occurred.Noise on both the carto 3 system and recording system were observed.The cable was replaced with no resolution.Catheter replacement resolved the issue.No adverse patient consequences were reported.The noise issue has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because on 3/18/19, the bwi pal received the device for evaluation and during a initial visual inspection observed damaged rings on spine c.The observed damaged rings on spine c have been assessed as mdr reportable as the device integrity was compromised.Further testing was performed and on 4/5/2019, the bwi pal performed scanning electron microscope (sem) testing and found two electrodes damaged and lifted.Both the damaged rings on spine c and damaged electrodes have been assessed as mdr reportable.The awareness has been reset to 3/18/2019.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a penta ray nav high-density mapping eco catheter and the biosense webster inc.(bwi) product analysis lab (pal) observed damaged electrodes and rings on spine c.On 4/23/2019 during an internal review, it was noticed that the manufacture address in the initial was erroneously reported as 31 technology dr.Irvine, ca 92618.The correct address is 33 technology dr.Irvine, ca 92618.Section d3 of this report has been updated.The bwi product analysis lab received the device for evaluation.The investigational analysis completed on 4/30/2019.The device was inspected and the rings on spine c were observed damaged.Irrigation testing was performed and the catheter was found to be flushing correctly.Electrical testing was performed and the catheter failed.No electrical readings were observed on electrode # 10.A failure analysis was performed and the catheter was dissected on the tip area.The electrical wire was found broken causing the improper electrical signal.The outer diameter of the catheter was measured and it was found within specification.Scanning electron microscope testing was performed on the damaged area.The results showed two pentaray electrodes damaged and lifted.There is evidence of mechanical damage and polyurethane borders were separated from their respective rings.It is possible that the damage was caused by an unknown object.No other anomalies were observed.A manufacturing record evaluation was performed and no non-conformances related to the reported complaint were identified.  the customer complaint was confirmed.The root cause of the electrical wire breakage and the damage observed on the electrodes cannot be related to the manufacture process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the manipulation of the device during the procedure.However, this cannot be conclusively determined.Manufacturer ref no:(b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology dr.; irvine CA 92618
• MDR Report Key: 8505875
• Report Number: 2029046-2019-02970
• Device Sequence Number: 10812531
• Product Code: MTD
• UDI-Device Identifier: 10846835012217
• UDI-Public: 10846835012217
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2021
• Device Catalogue Number: D128207
• Device Lot Number: 30119179L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1