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

Model Number	12TLW804F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.
Event or Problem Description
As reported, during procedure, this fogarty embolectomy catheter broke due to previous guidewire breakage.There was no allegation of patient injury.Patient demographic information unable to be obtained.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation).Updated section d9, h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).The device was received for evaluation.The report of broken catheter was confirmed.As received, catheter was found completely cut at approximately 22.9cm from distal tip.Cut appeared straight and even.Mating part was not returned.Balloon inflation could not be performed due to cut catheter.Guidewire was not returned.No visible damage was noticed from balloon.No other visible damage from returned catheter body.Lab findings were aligned with customer photo.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Based on the available information it cannot be confirmed that this complaint is associated to a manufacturing or design defect.As part of the manufacturing process, the units go through a final visual inspection for catheter tube integrity and leaks.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARD LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19727891
• Report Number: 2015691-2024-05300
• Device Sequence Number: 15535739
• Product Code: DXE
• UDI-Device Identifier: 00690103043518
• UDI-Public: (01)00690103043518(17)260124(11)231026(10)65357076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 01/24/2026
• Device Model Number: 12TLW804F
• Device Lot Number: 65357076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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