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

Model Number	120602F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our product evaluation lab received one 120602f catheter.The spring tip was stretched.Adhesive was visible at spring tip, indicating the spring was not broken.The balloon was completely torn at 0.02 inches from the proximal windings.The broken-off balloon with distal balloon windings were detached from the spring tip and were not returned.Per 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.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.The device history record review was completed and documented that the device met all specifications upon distribution.Report of the balloon tip broke was confirmed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
Event or Problem Description
It was reported that a 120602f fogarty catheter balloon tip broke off when pulling it out of the leg.The balloon remained inflated when taking the clot out.The tip broke off, exposing the inner wire.There was no patient injury, and no additional procedures or imaging was required due to the product malfunction.
Additional Manufacturer Narrative
Engineering evaluation was completed and concluded that a product risk assessment escalation was generated earlier to address balloon failures with fogarty embolectomy catheters.Corrections to the h6 codes investigation findings and investigation conclusions were made.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: FOGARTY ARTERIAL 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 17557187
• Report Number: 2015691-2023-15271
• Device Sequence Number: 3639730
• Product Code: DXE
• UDI-Device Identifier: 00690103043273
• UDI-Public: (01)00690103043273(17)250605(11)230307(10)64889747
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2025
• Device Model Number: 120602F
• Device Lot Number: 64889747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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