MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; FOGARTY CATHETER

Model Number 120804F

Device Problems Material Separation (1562); Component Missing (2306); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the balloon became detached from a fogarty arterial embolectomy catheter during thrombectomy procedure of the femoral artery.The balloon detached from the catheter while removing thrombus.A resistance was felt when the catheter was entered to the superficial circumflex iliac artery.The catheter was removed from the body and the tip of the balloon was found missing.Thrombectomy was continued with a new catheter.Massive thrombus was removed but it was unable to find the missing balloon tip in the removed thrombus.Since thrombus aspiration was also performed, the balloon fragment could have aspirated together.The results of computed tomography (ct) and x-ray showed that there was no possibility of missing balloon remaining in the patient body.The patient outcome was reported as ¿recovered¿.The patient is (b)(6) male with a medical history of atrial fibrillation and dementia.The initial is ks.The hospital reported that the severity of this event was not serious and that the event occurrence was not related to the device malfunction.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One fogarty arterial embolectomy catheter was returned for evaluation without any attached components.As received, the balloon latex, distal windings, and proximal windings were missing and not returned.Closer examination found that the catheter tip was broken off and the broken tip was not returned.Cross surface of the broken section appeared uneven and rough.Indication of windings was observed on the catheter body.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)".Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of balloon issue was confirmed.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.In this event, the catheter¿s balloon and both the distal and proximal windings were missing and not returned.Closer examination found that the catheter tip was broken off and the broken tip was not returned.The windings are meant to hold the balloon in place.If the windings are not securely attached to the catheter, the windings and/or balloon could detach while in use.Therefore, the potential for patient injury is not remote.In addition, 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.To minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.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.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.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 ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9036607
• MDR Text Key: 196991393
• Report Number: 2015691-2019-03420
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• 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: 09/02/2019

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 Model Number: 120804F
• Device Catalogue Number: 120804F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 10/03/2019; 07/23/2020
• Supplement Dates FDA Received: 10/25/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR