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

Model Number 120803F

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.¿ it is unknown whether user or procedural factors contributed to the stated event.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.

Event Description

It was reported that during use of an embolectomy catheter, the catheter tip broke in the vessel when they pulled out the blood clot.They do not know if the loose piece is stuck in the plug or if it remains in the patient.There was no allegation of patient injury and upon follow-up, the nurse stated the patient ¿is feeling well right now¿.The model and lot number of the suspect device are unknown.It is unknown if the device is available for return, as it was mentioned that the patient had blood contamination.

Manufacturer Narrative

Per new information obtained from the surgeon, the balloon was tested prior to the procedure by inflating it with a 1ml syringe and was noted to ¿be functional without remarks¿.When the balloon ¿snapped and parts of the balloon went missing¿ in the patient, it was ¿impossible to see if the remains of the balloon were still in the patient or if the remains were removed¿.It was also noted that the 51-year-old male patient involved in the event subsequently underwent an unspecified amputation because of massive thrombosis unrelated to the balloon ¿snapping¿ and the use of the product.The device could not be returned due to exposure to hepatitis.The model and lot number of the suspect device were also obtained.A review of the device history record has been initiated and upon completion, a supplemental report will be submit with the findings.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

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: 9687399
• MDR Text Key: 194478514
• Report Number: 2015691-2020-10451
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 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: 05/23/2021
• Device Model Number: 120803F
• Device Catalogue Number: 120803F
• Device Lot Number: 61900492
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/18/2020; 02/18/2020; 07/23/2020
• Supplement Dates FDA Received: 02/17/2020; 02/20/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR