MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; K892410

Model Number 12TLW803F

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

One fogarty catheter with attached bd 1.0 ml syringe was returned for evaluation.A small piece of ruptured balloon, customer alleged it is the piece removed from the patient, was returned with catheter.Blood was visible on catheter body.The balloon was found to be ruptured around the circumference and inverted to the distal side.After returning the balloon latex to the original position, the ruptured edges were not able to match up.The small piece of returned balloon latex, approximately 1 cm in length, did not appear to match up with the ruptured balloon edge.A closer examination found that the surface of balloon latex and the returned piece had different appearances.Per the ifu "balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures" and "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter.See specification table." there is no visible damage to the balloon windings, catheter body, or returned syringe.Through lumen was patent without any leakage or occlusion.The returned material will be sent to chemistry for testing.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of balloon issue was confirmed.A supplemental report will be sent with the chemistry investigation results.

Event Description

It was reported that the balloon of the fogarty catheter ruptured and a portion of the balloon was retained in the patient during shunt operation.The operative time was considerably prolonged since it was very difficult to remove the portion of the balloon.Additionally, the doctor reported that all remaining fragment was removed but it was unable to obtain how the fragment was removed.Patient status was defined as patient is doing well after the surgery.Patient demographic information requested but unavailable.

Manufacturer Narrative

Two samples (unknown material and balloon latex sample from lab ) were sent to chemistry for material identification and spectra comparison.One sample was the unknown material returned by the customer, alleged to be a piece of ruptured balloon latex.The second sample was a lab sample of balloon latex.Scanning electron microscopy-energy dispersive spectroscopy (sem-eds) testing was performed on the material returned from the customer.Ir spectrum of the unknown brown material returned from the customer showed similar absorption characteristic when compared to zein.(results from sem-eds scan 1 indicated the presence of the following elements: carbon, nitrogen, oxygen, sodium, magnesium, silicone, phosphorus, sulfur, potassium and calcium.) zein is a component that is contained in some clot busting drugs.It was unable to be verified if the patient was given clot busting drug before or during the procedure.Ir spectrum of the beige material /lab sample of balloon latex showed similar absorption characteristic when compared to latex.Results from sem-eds scan 2 indicated the presence of the following elements: carbon, nitrogen, oxygen, sodium, sulfur, chlorine, and iodine.The presence of iodine indicates the use of contrast.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.It is common clinical practice to inspect all products before use.The instructions for use for the product contains the following statement: ¿as with all catheterization procedures, complications may occur.These may include local or systemic infection, local hematomas, intimal disruption, arterial dissection, perforation and vessel rupture, hemorrhage, arterial thrombosis, distal embolization of blood clots and atherosclerotic plaque, air embolus, aneurysm, arterial spasm, arteriovenous fistula formation, and balloon rupture with fragmentation, tip separation and distal embolization.¿ to minimize these risks, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.Balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.In this event, there were no patient complications noted.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: K892410
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9508623
• MDR Text Key: 188680126
• Report Number: 2015691-2019-04848
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

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 Expiration Date: 12/14/2020
• Device Model Number: 12TLW803F
• Device Catalogue Number: 12TLW803F
• Device Lot Number: 61495863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/22/2019
• Supplement Dates Manufacturer Received: 02/02/2020; 07/23/2020
• Supplement Dates FDA Received: 02/19/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1