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

Model Number 120804F

Device Problems Backflow (1064); Break (1069); Material Rupture (1546); Material Separation (1562); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199); Stenosis (2263); Foreign Body In Patient (2687); Foreign Body In Patient (2687)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.Udi #: (b)(4).

Event Description

Per medwatch report mw5084112, it was reported that the balloon on a fogarty catheter broke and remained inside the patient.Per follow-up with the customer, the issue occurred in a male patient in his early eighties during thrombectomy of a dialysis access graft via the right groin.At least 2 fogarty catheters were used in the procedure to try and clear the clot.Due to extensive chronic changes in the graft with calcification, as well as some recalcitrant clot, it was difficult clearing all of the clot and despite how much clot was cleared, the patient would seem to reaccumulate.During maneuvers to remove the clot with the fogarty catheters, there were "1-2 episodes" where the balloon popped during withdrawal of the clot; however, both the catheter and the popped balloon were removed and checked, and there was no retained material within the patient.The customer re-iterated that this occurred only in the graft section.The surgeon proceeded to try to establish inflow in the graft and that seemed inadequate.They then moved towards the venous end but there was also a rather significant stenosis on that side, so a 6 x 4 angioplasty balloon (not a fogarty catheter balloon) was directly placed into the anastomosis.That angioplasty balloon was then inflated at the anastomosis to help dilate the stenosis, but that was also unsuccessful.Additionally, there was venous back bleeding for a minute or so but later in the case it diminished back down to a minuscule amount.It is unknown if the balloons on the fogarty catheters were tested prior to insertion.There was no patient injury and the patient was discharged.The model and lot number of the second reported catheter are unknown.

Manufacturer Narrative

Associated mdr report # 2015691-2019-01083.

Manufacturer Narrative

The customer was unresponsive to multiple attempts for return of the product.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint; however, without the return of the product, it is not possible to determine if any damages or defects exist on the product, nor can any product nonconformance or device failure mode be confirmed.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.To minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.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 thrombosis, distal embolization of blood clots and atherosclerotic plaque, air embolus, aneurysm, arterial spasm, arteriovenous fistula formation, and balloon rupture with fragmentation, tip 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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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: 8461333
• MDR Text Key: 140920748
• Report Number: 2015691-2019-01082
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/05/2019
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 120804F
• Device Catalogue Number: 120804F
• Device Lot Number: 61027249
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 03/28/2019; 04/30/2019; 07/23/2020
• Supplement Dates FDA Received: 04/01/2019; 05/17/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Age: 80 YR