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 Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation onseptember 8, 2020.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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and the device tip fully separated.One branch (spline) was broken.It was reported that after the synaptic 8.5 f sheath was inserted into the right atrium, one spline of the pentaray nav high-density mapping eco catheter got stuck in the irrigation hole of the sheath and broke.The pentaray nav high-density mapping eco catheter, the sheath and broken spline were removed on site.There was no injury reported.Procedure was completed by another catheter.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The broken spline was assessed as an mdr reportable tip fully separated issue.The impeded device was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

The device evaluation was completed on 10/8/2020.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and the device tip fully separated.One branch (spline) was broken.It was reported that after the synaptic 8.5 f sheath was inserted into the right atrium, one spline of the pentaray nav high-density mapping eco catheter got stuck in the irrigation hole of the sheath and broke.The pentaray nav high-density mapping eco catheter, the sheath and broken spline were removed on site.There was no injury reported.Procedure was completed by another catheter.An analysis was performed on the pictures that were provided by the customer.According to the pictures, one spline of pentaray nav high-density mapping eco catheter was observed stuck inside the sheath.The other splines cannot be observed on the pictures provided.This suggests that the spline was separated from the rest of the device.Customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find root cause of the complaint.The device was visually inspected and one of the splines was missing.The catheter passed the outer diameter (od) test and the measures were found with in specification.According to the instructions for use (ifu) this catheter is designed for deployment in a heart chamber through an 8 f guiding sheath.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the broken tip 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.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: 10512307
• MDR Text Key: 225600367
• Report Number: 2029046-2020-01199
• 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
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30314901L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI ¿ SYNAPTIC 8.5F SHEATH; UNKNOWN BRAND CATHETER