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

Model Number	12TLW405F35
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 12tlw405f35 was returned for examination.The reported event of not inflate and deflate without using a lot of pressure was confirmed.As received, the balloon inflation lumen was found be occluded.There was unknown radiopaque material found at multiple locations in the inflation lumen.A cut down was performed on the catheter body.Inflation lumen was found to be occluded with unknown clear gel-liked material.With a tuohy borst connector, the balloon was inflated with 1.7ml air and the balloon inflated concentric and did not leak.The balloon was able to be deflated completely within 2 seconds.The balloon was also inflated with 0.9ml di water but it could not be deflated completely by pulling back on the syringe plunger.Balloon inflation lumen was found to be collapsed near the proximal windings.The balloon latex, bushings and windings were intact.Through lumen was patent without any leakage or occlusion.There was no visible damage observed from catheter body.The unknown material will be sent to chemistry for further analysis.Per the ifu, "use of liquid inflation media will result in slower inflation/deflation rates".A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.Udi number: (b)(4).
Event or Problem Description
It was reported that a fogarty was opened and the balloon did not inflate and deflate properly.The balloon would eventually deflate but took more than a minute.It was tested before procedure started so there was no patient involvement.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12756109
• Report Number: 2015691-2021-06158
• Device Sequence Number: 9212345
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)230908(11)210609(10)63797460
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K892410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2023
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 63797460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown