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

Model Number 120404F

Device Problems Break (1069); Entrapment of Device (1212); Retraction Problem (1536); Material Separation (1562); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 07/30/2019

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

It was reported that the tip of a fogarty embolectomy catheter detached from the catheter and fell into the patient during use.The catheter was introduced up the venous limb and the thrombus was removed.During withdrawal resistance was met.When the catheter was removed, it appeared that the tip of the catheter had broken off, measuring 6 mm in length.Several unsuccessful attempts were made to retrieve the tip.The vessel was ultimately tied off.There was no allegation of patient injury or consequence.Patient demographics were requested and not provided.

Manufacturer Narrative

Our product evaluation laboratory received one model 120404f catheter.The tip of the catheter tube was broken at the distal inflation port.The catheter tip with the balloon latex and distal balloon windings were missing.No other visible damage was observed from the catheter body.The customer report of "cather tip detached" was confirmed on evaluation.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.¿ 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

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: 8884005
• MDR Text Key: 188842869
• Report Number: 2015691-2019-02990
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: 120404F
• Device Catalogue Number: 120404F
• Device Lot Number: 61899024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention