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

Model Number VASUNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombus (2101)

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.Four cases of complications occurred in the fogarty catheter group which were captured in mdr's 2015691-2020-13605 and 2015691-2020-13607.The fogarty adherent clot catheter is indicated for the removal of emboli and thrombi from either native vessels or synthetic grafts in the arterial system.To minimize the risk of vessel or membrane damage, the maximum recommended pull force for the catheter should not be exceeded.The instructions for use of 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 thrombolysis, distal emboli or blood clots or arteriosclerotic plaque, air emboli, aneurysms, arterial spasms, arteriovenous fistula formation, membrane separation 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.Medwatch number 2015691-2020-13652 for ruptures detailed in the journal article and medwatch number 2015691-2020-13653 for distal thrombus embolization.

Event Description

It was reported that in a journal article published in 2015 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.In the ac catheter group, 12 ruptures occurred: 3 events with venous outlet rupture solved by balloon angioplasty, 3 graft ruptures that were solved by primary closure and 6 fistula ruptures that were solved by patchy angioplasty.Additionally, distal thrombus embolization occurred in 2 cases and obstruction in 3 cases.Model and lot numbers are unknown.As well as any specific patient demographics.The devices were not saved for examination.

• Brand Name: FOGARTY ADHERENT CLOT 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; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492502904
• MDR Report Key: 10557438
• MDR Text Key: 207715124
• Report Number: 2015691-2020-13655
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K901625
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 08/28/2020
• 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): Other; Required Intervention