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

Catalog Number D128211

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

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.A manufacturing record evaluation was performed for the finished device 30186146l number, and no internal actions related to the reported complaint condition were identified.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab has identified metallic braid exposure.It was initially reported that during the afib operation, the pentaray nav high-density mapping eco catheter could not deflect to the specification.A second catheter was used to complete the operation.There was no patient consequences.The customer¿s reported deflection issue is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 8/15/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found the proximal end of the sleeving was cracked at the transition with the tip lumen.This finding was assessed as a reportable malfunction since the device integrity was compromised.On 8/30/2019, during a second visual analysis, the crack was observed again along with a kink on the tip next to window with metallic braid exposure.The finding of the crack continues be to considered mdr reportable.The metallic braid exposure from the kinked part has also been assessed as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab has identified metallic braid exposure.It was initially reported that during the afib operation, the pentaray nav high-density mapping eco catheter could not deflect to the specification.A second catheter was used to complete the operation.There was no patient consequences.The customer¿s reported deflection issue is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 8/15/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found the proximal end of the sleeving was cracked at the transition with the tip lumen.This finding was assessed as a reportable malfunction since the device integrity was compromised.On 8/30/2019, during a second visual analysis, the crack was observed again along with a kink on the tip next to window with metallic braid exposure.The finding of the crack continues be to considered mdr reportable.The metallic braid exposure from the kinked part has also been assessed as mdr reportable.Device evaluation details: the device evaluation has been completed.The device was visually inspected, and it was found with an open crack in the transition with the tip lumen.Additionally, a kink was found on the tip next to the window with the metallic braid exposed.Then, the deflection test was performed, and the catheter failed.A failure analysis was performed, and the catheter handle was opened; the puller wire was found broken causing the deflection issue.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The complaint reported by the customer has been confirmed.The root cause of the puller wire broken and the damage on the 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, however, this cannot be conclusively determined.Additionally, the customer provided photos with evidence of the catheter piston observed up with tip semi deflected.Customer complaint was confirmed with pictures provided.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: 9013098
• MDR Text Key: 158638637
• Report Number: 2029046-2019-03629
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2022
• Device Catalogue Number: D128211
• Device Lot Number: 30186146L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1