MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ADHERENT CLOT CATHETER; FOGARTY CORKSCREW CATHETER

Model Number 140806

Device Problem Retraction Problem (1536)

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

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation lab received one model 140806 adherent clot catheter with an attached non-ew introducer, which was located at 18.5cm to 28.5cm proximal from the catheter tip.As received, the latex membrane was in the contracted position and the spiral cable was distorted.A tear of 1.5mm in size, was found on the proximal side of the latex membrane and the spiral cable was exposed from the tear.The edges of the tear appeared to match up.The latex membrane was found to be moved towards the distal and proximal side.The latex membrane was returned to the original position and no visible damage was observed from the bonding sites of the membrane.The catheter was received in three sections, 75cm to the tip with 3.8 cm of core wire exposed, the handle and 4.5cm of catheter attached, and a 3.8cm section of catheter tube detached from the main catheter body.The edges of the catheter tubes were rough, uneven and did not appear to match up.The edges of the core wire also did not appear to match up.A kink was observed at 22.5cm proximal from the catheter tip.That region is noted to be the same as the non-ew introducer folded region.The thumb slide on the handle moved forwards and backwards, but the wire did not move.The handle was opened, and the core wire was found to be kinked and broken near the thumb slide.No other defect was found on the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of the membrane unable to move even though the control button was actuated was confirmed on evaluation.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 after the membrane of the fogarty catheter, model 140806 from lot 64274377, was expanded in the body of the patient, the membrane became unable to move even though the control button was actuated.No additional treatment nor new access site were required at the time of the catheter removal.There were no patient complications reported.Additional information reported that the membrane of the catheter did not move back from the expanded position and had to be cut from outside of the body of the patient to be removed successfully.

• Brand Name: FOGARTY ADHERENT CLOT CATHETER
• Type of Device: FOGARTY CORKSCREW CATHETER
• 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 ; one edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16251241
• MDR Text Key: 309055419
• Report Number: 2015691-2023-10389
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103042412
• UDI-Public: (01)00690103042412(17)240629(11)220331(10)64274377
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K901625
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2023

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 Model Number: 140806
• Device Catalogue Number: 140806
• Device Lot Number: 64274377
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1