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

Model Number 120602FP

Device Problem Deflation Problem (1149)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

As reported, during a fenestration of the medial membrane and artery with this fogarty embolectomy catheter, the balloon remained full, making it difficult to extract, with the risk of hemorrhage from the site.After this episode, another catheter is placed with the same batch, being able to end the procedure.There was no allegation of patient injury.The device was available for evaluation.

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.

Manufacturer Narrative

Added: d4 (expiration date), h4 (device manufacturing date), h6 (type of investigation).Updated: b5 (description), h3 (device evaluated by manufacturer), h6 (health effect - clinical code, investigation findings, investigation conclusion).The device involved in this complaint was not available for evaluation.The manufacturing records were reviewed 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 balloon and winding inspection process.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.H3 other text : not returned for evaluation.

Event Description

As reported, during a fenestration of the medial membrane and artery with this fogarty embolectomy catheter, the balloon remained full during 90 seconds, making it difficult to extract.They proceed to remove it by force, not completely deflated, with the risk of hemorrhage from the site.The patient bleed approximately one cubic centimeter.After this episode, another catheter is placed with the same batch, being able to end the procedure.After surgery, the patient was on state of alert, awake and started physical therapy as it suffered partial fourth nerve paralysis, however the patient recovered and was discharge.The device was not available for evaluation.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: samantha ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18266761
• MDR Text Key: 329728702
• Report Number: 2015691-2023-17926
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 120602FP
• Device Lot Number: 64252737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female