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 Rupture (2208)

Event Date 08/01/2012

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.A supplemental report will be forthcoming to cross reference the medwatch report for the reported event of obstruction.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.Yang, yu sung, et al."clinical experience with a hybrid procedure using the adherent clot catheter for salvage of thrombosed hemodialysis access: a comparison with the standard fogarty balloon catheter." vascular specialist international 31.1 (2015): 25.

Event Description

It was reported that in a journal article published in 2014 and titled ¿clinical experience with a hybrid procedure using the adherent clot catheter for salvage of thrombosed hemodialysis access: a comparison with the standard fogarty balloon catheter¿.The study compared the efficacy of an adherent clot (ac) catheter to the standard balloon fogarty catheter for clot removal in thrombosed hemodialysis access, 4 cases of complications occurred in the fogarty catheter group.In the standard fogarty catheter group, there were 2 events reported with venous outlet rupture which were solved by performing a balloon angioplasty and 2 events with obstruction.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 number 2015691-2020-13607 that cross-references the events of obstruction events in the journal 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; anaso PR 00610
• MDR Report Key: 10551230
• MDR Text Key: 207528184
• Report Number: 2015691-2020-13605
• 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: 08/28/2020

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