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.Obstruction can partially or totally restrict the flow through the vessel, or it can separate/break and embolize distally in critical blood vessels resulting in tissue damage.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.Please see medwatch number 2015691-2020-13605 that cross-references the venous outlet rupture in the article.

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¿.As per the article, 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 number 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; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492502904
• MDR Report Key: 10551285
• MDR Text Key: 207497086
• Report Number: 2015691-2020-13607
• 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: 08/28/2020

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
• 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): Required Intervention