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

Model Number	120403F
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.
Event or Problem Description
It was reported via medwatch 4900240000 2023 8061 that the balloon separated from the catheter after use.Catheter was inspected by doctor and noted that the balloon was intact prior to use.After use, the balloon was no longer attached and was unable to be located on the sterile field.Forgarty was passed proximal in the superior mesenteric artery.On the last proximal pass, the balloon appeared to have broke and could not be found.Per follow up with customer, there were no further attempts made to retrieve or locate missing balloon, no troubleshooting attempts made, no additional products used, and no patient injuries.
Additional Manufacturer Narrative
The reported event of balloon separated from the catheter 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.Per the ifu, balloon rupture and catheter separation as a result of excessive pull force applied to remove adherent material are the most frequent causes of reported failures and to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation and pull force for each size catheter.No other visible damage was observed from catheter.Further evaluation regarding related quality issues is under investigation.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.
Additional Manufacturer Narrative
An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.It concluded that a product risk assessment was previously generated to cover embolectomy catheters with detached spring tip.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.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 ARTERIAL 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: 16899300
• Report Number: 2015691-2023-12886
• Device Sequence Number: 5459267
• Product Code: DXE
• UDI-Device Identifier: 00690103043242
• UDI-Public: (01)00690103043242(17)250219(11)221121(10)64703421
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 07/14/2023

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
• Device Expiration Date: 02/19/2025
• Device Model Number: 120403F
• Device Catalogue Number: 120403F
• Device Lot Number: 64703421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 07/07/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/08/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 82 KG