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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES, PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; FOGARTY CATHETER Back to Search Results
Model Number 12TLW404F
Device Problems Deflation Problem (1149); Product Quality Problem (1506)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2019
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 did not deflate during use.The customer commented that the catheter was able to be removed with the balloon remaining inflated without making an additional incision.The reporter commented that the blood vessel was relatively wider than the balloon.Patient demographic information requested but unavailable.There were no patient complications reported.
 
Manufacturer Narrative
One fogarty catheter with attached bd 3 ml syringe was returned for evaluation.Blood was observed from the catheter body.The balloon was inflated with 1.2 cc air for 5 minutes and was found to be eccentric.There is no deflation specification using air as the inflation media.The balloon was again inflated using 0.5 cc water and the balloon inflated eccentrically and did not leak for 5 minutes.Balloon deflation was achieved in 5.1 sec by pulling back on the syringe plunger as recommended.The specification for balloon deflation is 15 seconds while pulling back on the syringe plunger.Eccentricity was found to be 0.17" (rmax = 0.24¿, rmin = 0.07¿) and the specification for eccentricity is 0.080".The through lumen was 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 ¿the balloon did not deflate¿ could not be confirmed; however, balloon eccentricity was confirmed during analysis.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.
 
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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 Key8617812
MDR Text Key145503261
Report Number2015691-2019-01764
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
PMA/PMN Number
K892410
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/22/2019
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 Date01/27/2021
Device Model Number12TLW404F
Device Catalogue Number12TLW404F
Device Lot Number61561864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2019
Initial Date Manufacturer Received 04/22/2019
Initial Date FDA Received05/16/2019
Supplement Dates Manufacturer Received05/16/2019
07/23/2020
Supplement Dates FDA Received06/07/2019
01/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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