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

Model Number VASUNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Ischemia (1942)

Event Date 11/15/2019

Event Type  Injury  

Manufacturer Narrative

The devices were not returned for evaluation.Without return of the units it is not possible to determine if some damage or defect existed on the units that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore, review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Per the ifu, the arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).The catheter is not designed to withstand the additional force needed to remove these materials.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 possibility of balloon rupture must be taken into account when considering the risks involved any embolectomy procedure.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 and distal embolization.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.Cho, s.B., choi, h.C., lee, s.M., na, j.B., park, m.J., shin, h.S.,.& park, s.E.(2019).Combined treatment (image-guided thrombectomy and endovascular therapy with open femoral access) for acute lower limb ischemia: clinical efficacy and outcomes.Plos one, 14(11), e0225136.Medwatch number 2015691-2020-13600 cross references the complaints for arterial extravasations.

Event Description

It was reported that in a journal article published in 2019 and titled ¿combined treatment (image-guided thrombectomy and endovascular therapy with open femoral access) for acute lower limb ischemia: clinical efficacy and outcomes¿ 52 patients underwent combined treatment for acute thrombotic occlusion of lower extremity arteries.In 10 patients using fogarty catheters, there were 5 cases of extravasation and 5 cases of arterial dissection.The arterial extravasations were: one popliteal, three peroneal, one posterior tibial.The popliteal artery was treated with embolization and stenting, one peroneal artery was embolized with microcoils while the two peroneal arteries and one posterior tibial artery could be treated with long-duration balloon inflations.Model and lot numbers are unknown.As well as any specific patient demographics.The devices were not saved for examination.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, 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; anasxo PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 10551092
• MDR Text Key: 207505526
• Report Number: 2015691-2020-13602
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VASUNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention