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

Model Number	12TLW405F35
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The reported deflation issue was confirmed.The balloon inflated with 1.7ml of air and it inflated concentric and did not leak.Resistance was felt when inflating with distilled water.The balloon could not be deflated completed after 15 seconds by pulling back on the syringe plunger.Cut down was performed on the catheter body to locate occlusion.Balloon inflation lumen was found to be collapsed near the proximal windings.Balloon latex, bushings and windings were intact.The thru lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body.An engineering task has been assigned for further investigation.The device history record review has been completed and all manufacturing inspections passed with no non conformances.
Event or Problem Description
It was reported that there was a malfunction with a fogarty thru lumen embolectomy catheter, during use.Per the customer, the technician that was in the case did not prep the device before starting the case.The issue could have been found before use.The doctor was able to inflate the catheter balloon, but could not deflate enough to pull it out of the sheath.The sheath and the catheter were removed and a new sheath was inserted with a new catheter.There was no patient injury or harm.
Additional Manufacturer Narrative
The engineering evaluation was completed.The root cause was determined to be manufacturing, associated with the collapse of the balloon inflation lumen.The instructions for use ifu, instructs the user that the catheter should be inspected with the balloon inflated during purging.In addition, as part the manufacturing process, 100 percent of the units are inspected.A product risk assessment was completed and no unreasonable risks were identified.A capa was opened to assess for any corrective actions required for this issue.Corrective actions were implemented to address manufacturing non-conformance.

• Brand Name: FOGARTY THRU LUMEN EMBOLECTOMY CATHETER
• Common Device Name: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk km 1.4; anasco PR 00610
• Manufacturer Contact: katheryn cespedes ; 1 edwards way; irvine, CA 92614 ; 9492017706
• MDR Report Key: 18942810
• Report Number: 2015691-2024-02145
• Device Sequence Number: 8381745
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)260131(11)231102(10)65345587
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 01/31/2026
• Device Model Number: 12TLW405F35
• Device Lot Number: 65345587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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