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

Model Number	12TLW405F35
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	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon on a fogarty catheter separated from the catheter while still in the patient.No snare was used to remove the separated balloon.Instead, the doctor used another fogarty with a bigger introducer to pin device and remove balloon.No additional troubleshooting steps were attempted, no other edwards products were involved, and no patient injuries reported.
Additional Manufacturer Narrative
The device was discarded.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.
Additional Manufacturer Narrative
Per additional information from customer, issue was resolved with another fogarty with a bigger introducer to pin device and remove balloon.No snare or additional troubleshooting steps were used to remove the separated balloon, no other edwards product were involved in the incident, and they confirmed there were no patient injuries.Although device was discarded, customer provided a photo of the catheter involved.An evaluation was completed with the provided one image.The reported event of balloon separation was unable to be confirmed from the image.Image showed an overall picture of two 12tlw405f35 catheters with a broken body tube and two syringes.The condition of the balloon was unable be determined from the image.Blood was visible on the syringes and catheters.First catheter from the top of the picture appeared intact, and there was no visible broken part.Second catheter was completely broken into two at approximately 13 cm from tip.Further evaluation regarding related quality issues is under investigation.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 a part of the monthly review.
Additional Manufacturer Narrative
Updates to the h6 codes are as follows investigation findings was changed to no findings available and investigation conclusions was changed to cause not established.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 16683056
• Report Number: 2015691-2023-12112
• Device Sequence Number: 17965313
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)250501(11)230131(10)64820928
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2023

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
• Device Expiration Date: 05/01/2025
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 64820928
• Was Device Available for Evaluation?: No
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 05/09/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/03/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown