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

Model Number 12TLW804F

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Event Description

As reported, during use in patient, the balloon of this fogarty embolectomy catheter could not be deflated.The issue was solved exchanging by a new device.There was no allegation of patient injury.Patient demographics unable to be obtained.

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

Updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions).Added: d4 (expiration date), h4 (device manufacturer date).The fogarty catheter was sent to our product evaluation laboratory for a full evaluation.As received, both balloon and windings were intact.However, balloon could not be inflated and back pressure was observed from balloon inflation lumen.Unknown clear material was found at approximately 60 millimeters from catheter tip.The through lumen was found to be patent and did not leak.No other visible damage or inconsistency were observed from catheter body.Customer report of "catheter could not be deflated" was unable to be confirmed during product evaluation due to inflation lumen occlusion.Unknown clear material was sent to chemistry for further evaluation.As per chemistry analysis: ''ir spectrum of unknown material showed similar absorption characteristics when comparing to ''aluminum oxide''.However, the spectrum showed a match of 62.27%.The bill of materials of the product was verified, and this substance was not identified to be used in the catheter manufacturing process.Further investigation was performed by the engineers in the manufacturing site.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.The occlusion was found after the product evaluation, which may be related to the use of contrast medium when inflating the balloon.As part of the catheter manufacturing process, units go through a balloon integrity inspection.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.Additionally, per ifu, "use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded".

• Brand Name: FOGARTY THRU-LUMEN 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18299635
• MDR Text Key: 330118246
• Report Number: 2015691-2023-18258
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 12TLW804F
• Device Lot Number: 64727955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2022
• 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