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 Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrilation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the tip became partially detached.It was reported that after the pentaray nav high-density mapping eco catheter was used successfully and withdrawn outside of patient, it looked good.But after a while, when physician finished the ablation and wanted to use pentaray nav high-density mapping eco catheter again, he found it fractured.A second catheter was used to complete the operation.There was no report on adverse event on patient.On 12/11/2019, biosense webster inc.Received additional information about the even and product.It was reported that there were no sharp or lifted rings.It is unknown if there was any resistance during insertion or removal.A st.Jude sheath was used.The customer provided images showing extensive damage to the tip assembly.The details of these event are not clear.It is most likely that the damage was inflicted outside of the patients body.However, since there is remote possibility that the damage was missed by the physician on initial inspection, with the available information this event will be conservatively reported.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrilation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the tip became partially detached.It was reported that after the pentaray nav high-density mapping eco catheter was used successfully and withdrawn outside of patient, it looked good.But after a while, when physician finished the ablation and wanted to use pentaray nav high-density mapping eco catheter again, he found it fractured.A second catheter was used to complete the operation.There was no report on adverse event on patient.On 12/11/2019, biosense webster inc.Received additional information about the even and product.It was reported that there were no sharp or lifted rings.It is unknown if there was any resistance during insertion or removal.A st.Jude sheath was used.The customer provided images showing extensive damage to the tip assembly.The details of these event are not clear.It is most likely that the damage was inflicted outside of the patients body.Device evaluation details: the device evaluation has been completed.The returned device was inspected and wires are exposed in the shaft 3 inches from the tip.Again, during the second visual analysis wires were found exposed at 3 inches from the tip.The received device was inspected under the microscope and determined tip and the cables show evidence of being cut by some sharp object.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been confirmed.The root cause of the tip broken 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.The customer had also provided photos of the reported issue.According to pictures provided, the tip was observed broken.Based on the pictures alone, the customer complaint had also been confirmed.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 1/6/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found wires are exposed 3 inches from the tip.The findings were reviewed and determined to be mdr reportable malfunction since the integrity of the device is not maintained.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.Additionally, 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: 9537071
• MDR Text Key: 200063051
• Report Number: 2029046-2019-04090
• 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: 12/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30241002L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/06/2020; 02/05/2020
• Supplement Dates FDA Received: 01/29/2020; 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ST. JUDE SHEATH