MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER

Model Number 12TLW805F35

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model 12tlw805f35 catheter with attached bd 3 cc syringe.The balloon was inflated but did not maintain its inflation due to air leakage from the catheter tip.A visual examination found a crack at inside of the catheter tip.The crack entered the inflation lumen.The length of crack could not be measured because it was inside of the tip.The edges of cracks did not appear to match up.The balloon inflation was observed when a leak test was performed with the thru-lumen.No other visible damages were observed from the catheter body, returned syringe, balloon and windings.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of the fogarty catheter unable to maintain its inflation was confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

It was reported that during the inflation test, the balloon of the fogarty catheter, model 12tlw805f35 from lot 64036596, could not maintain its inflation.Air leakage was observed from the connection between the gate valve and the syringe.There were no patient complications reported.

Manufacturer Narrative

An engineering evaluation was performed to assess for any manufacturing related causes.A capa was initiated and corrections/corrective actions were implemented successfully.A product risk assessment escalation was not required.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY THRU-LUMEN EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16338588
• MDR Text Key: 309194464
• Report Number: 2015691-2023-10703
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)240114(11)211015(10)64036596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 64036596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1