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

Model Number	120403F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, after heparin administration, clamping transversely the inflow and outflow with a number 11 blade and, being used proximally until having clean pass of the ulnar artery, this 3f fogarty catheter tip detached.The back bleeding was quite substantial; then, papaverine and warm saline were applied, being able to retrieve the fogarty catheter.Since it was unsure if the detached tip remained inside the patient, another 3f fogarty catheter was inserted all the way to the wrist but no obstruction was found.The arteriotomy was closed using 6-0 prolene sutures in running fashion from each apex.And the suture line was checked for hemostasis.Needle hole bleeding was controlled with the topical application of surgicel.Flow was re-established and confirmed to be excellent by cw doppler evaluation, that revealed triphasic flow signals to all branches confirming that the distal tip was not in the patient.Quantity of blood loss was unknown.Patient was discharged home with no complications a few days after the surgery.The device was available for evaluation.
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.
Additional Manufacturer Narrative
Added information to section h6 (type of investigation) updated section h6 (component code), h6 (investigation findings) and h6 (investigations conclusions).Finally, the device was not available for evaluation despite due diligent attempts.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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.As part of the manufacturing process the units go through a balloon winding and full visual inspection process.
Additional Manufacturer Narrative
Finally, the device was received for evaluation.The report of "catheter tip detached" was confirmed.As received, spring tip with balloon latex and distal windings were detached from catheter body and not returned.Proximal windings and catheter body were intact.No other visible damage was observed from catheter.Based on the available information there is no evidence that supports or confirms theses failure modes are associated to a manufacturing or design defect.It was verified that the manufacturing process have the controls to detect conditions related to balloon or spring tip.The units go through a final visual and inflation inspection process where the appearance of the catheter body is verified, the windings of the balloon are inspected and the balloon is inflated.Additionally, in the ifu it is indicated that the balloon rupture and catheter separation are the most frequent causes of reported failures as a result of excessive pull force applied to remove adherent material.Also, it is specified that to minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation and pull force for each size catheter must not be exceeded.

• Brand Name: FOGARTY
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 22192354
• Report Number: 2015691-2025-04775
• Device Sequence Number: 8837480
• Product Code: DXE
• UDI-Device Identifier: 00690103043242
• UDI-Public: (01)00690103043242(17)260716(11)240416(10)65680453
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K810352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2026
• Device Model Number: 120403F
• Device Lot Number: 65680453
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 03/11/2026
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/02/2025; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 93 KG