MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; FOGARTY CATHETER

Model Number 12TLW405F35

Device Problems Deflation Problem (1149); Inflation Problem (1310); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is in progress.A supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.

Event Description

It was reported that the balloon of the fogarty thru-lumen embolectomy catheter was difficult to inflate and deflate the balloon at the inflation test before use.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One fogarty catheter with attached bd 3.0ml syringe was returned for evaluation.The balloon and balloon windings were visually inspected for indication of damage or abnormality and there was no damage found.The balloon was inflated with 1.7 cc air and the balloon inflated clear and concentric for 5 minutes.There is no deflation specification using air as the inflation media.The balloon was again inflated using 0.9 cc water and the balloon inflated clear and concentric and did not leak for 5 minutes.Balloon deflation was achieved in 14.5 seconds by pulling back on the syringe plunger as recommended.The specification for balloon deflation is 15 seconds while pulling back on the syringe plunger.The through lumen was found to be patent without any leakage or occlusion.Balloon testing was performed using the returned syringe.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.Customer report of ¿it was difficult to inflate and deflate the balloon¿ could not be confirmed during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.The fogarty catheter is typically used on vessels that are already occluded so the potential for ischemia related to deflation difficulty in this set of circumstances, is less likely.However, deflation difficulty can also impair balloon modulation during use, which has the potential to lead to vascular injury; therefore, the potential for injury is not considered to be remote.It should be noted that the ifu clearly states in the warning section that: use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded.It is unknown whether user or procedural factors may have 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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8544513
• MDR Text Key: 143892340
• Report Number: 2015691-2019-01436
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2019

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: 02/14/2021
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 61579897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 07/23/2020
• Supplement Dates FDA Received: 05/31/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1