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

Model Number 120804FP

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The reported event of defective balloon was confirmed.Balloon latex appeared deteriorated and discolored.Multiple cracks and tears were evident on balloon latex.Leakage was observed through the tears on the balloon.Both balloon windings were intact.Balloon latex was released from proximal winding to check balloon edges at the tears.The edges did not appear to match at the tears.No other visible damage was observed from catheter body.Further evaluation regarding related quality issues is under investigation.Device lot number is either 64311190 or 64394004.For lot 64311190, manufactured date is 21apr2022, expiration date is 18jul2024, and udi is (b)(4).For lot 64394004, manufactured date is 18jun2022, expiration date is 14sept2024, and udi is (b)(4).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.

Event Description

It was reported the balloon of an arterial embolectomy catheter was defective.No other additional details were available.Lot number may be either 64311190 or 64394004.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.A product risk assessment was generated earlier in order to cover the balloons with fragmentations for embolectomy products.Additionally, a capa was generated to address balloons with latex deterioration failure for embolectomy models and is in the implementation phase.Updates to the h6 codes are as follows investigation findings was changed to environment problem identified and investigation conclusions was changed to cause traced to environment.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
• Type of Device: 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: 17670392
• MDR Text Key: 322499260
• Report Number: 2015691-2023-15657
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

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 Model Number: 120804FP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1