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

Model Number 12TLW805F35

Device Problem Deflation Problem (1149)

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

Event Type  malfunction  

Event Description

As reported, before use in patient, the balloon of this fogarty embolectomy catheter could not be deflated.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 been received yet.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

The device 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 10 centimeters from distal tip into the balloon inflation lumen.Material did not dislodge from the location during evaluation.As per chemistry analysis of the unknown material found in the inflation lumen, the sample spectrum did not exhibit a suitable match to any spectrum in the library.Customer report of "balloon could not be deflated" was unable to be confirmed during product evaluation.Further investigation was performed by the engineers in the manufacturing site.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully and as part of the manufacturing process, the units go through balloon inflation inspection.Per ifu, "use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded".The through lumen was found to be patent and did not leak.No other visible damage or inconsistency were observed from catheter body.Unknown clear material was sent to chemistry for further analysis.Based on the available information it cannot be confirmed that this complaint is associated to a manufacturing/design defect.

• 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 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18657345
• MDR Text Key: 334723933
• Report Number: 2015691-2024-00805
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12TLW805F35
• Device Lot Number: 65279774
• 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: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2023
• 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