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.A supplemental report will be forthcoming to cross-reference the event of arterial dissection.An allegation of ¿arterial extravasation¿ was made against an unknown fogarty catheter model, in which additional procedures were necessary to treat the injuries.Per the ifus (instruction for use) the arterial embolectomy and thur-lumen catheters are 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 pull force needed to remove these materials.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.

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.

Manufacturer Narrative

Please see medwatch 2015691-2020-13602 that cross-references arterial dissection events in the article.

• 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
• MDR Report Key: 10550703
• MDR Text Key: 207508400
• Report Number: 2015691-2020-13600
• 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: foreign,literature,other
• Type of Report: Initial,Followup
• 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
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention