MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, F, 2-6-2; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128208

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a pentaray nav high-density mapping eco catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a break at the tip shaft transition.Initially, it was reported that breakage was observed at the end of the catheter.Followup was performed to obtain details of breakage.On /10/2019, a response was received indicating additional details were unobtainable.Catheter replacement resolved the issue.No adverse patient consequences were reported.The initially reported breakage at the tip transition 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, is remote.On 10/17/2019, the bwi pal received the device for evaluation.Upon initial inspection, the product revealed no physical damage.Additional testing was performed.During a second visual inspection on 11/12/2019, the bwi pal found breakage in the tip-shaft transition, leaving internal parts exposed.The observed finding of the break at the tip shaft transition has been assessed as an mdr reportable malfunction as device internal components were exposed.The awareness date has been reset to 11/12/2019.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a pentaray nav high-density mapping eco catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a break at the tip shaft transition.Initially, it was reported that breakage was observed at the end of the catheter.The investigational analysis completed 1/15/2020.The device was inspected and no physical damage was observed.However, during a deeper investigation, a breakage was observed between the tip to shaft transition with internal parts exposed.A product analysis was performed by inspecting the transition and it was confirmed that the polyurethane was properly applied during the manufacturing process of the internal and external components.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the damage on the shaft to tip transition 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.Manufacture reference no: (b)(4),.

• Brand Name: PENTARAY NAV ECO 7FR, F, 2-6-2
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9419513
• MDR Text Key: 191861797
• Report Number: 2029046-2019-03962
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30229901L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1