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

Model Number 120803FP

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Adult female with left arteriovenous graft that is thrombosed to or for thrombectomy.During preparation of devices the balloons popped on all 3 prepped catheters.Tuberculin syringe was used.No patient harms.These were not introduced into patient.Staff just set these aside under the concerns that there were 3 at once at the heels of recent event of similar (3) devices.Eventually a #3 and #4 fogarty was passed retrograde.Acute thrombus was removed.An 8-french sheath was then placed through the graftotomy.A 0.028 wire was advanced proximally and a #4 over the wire fogarty was then used to perform additional thrombectomy.Distal outflow stenosis was 75% stenosis.This was stented with a 7 x 50 mm viabahn and post dilated to 6 mm.

• Brand Name: FOGARTY
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 13860805
• MDR Text Key: 287702747
• Report Number: 13860805
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2022

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 Model Number: 120803FP
• Device Catalogue Number: 120803FP
• Device Lot Number: 63954397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: American Indian Or Alaskan Native