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

Model Number 120404FP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

One fogarty embolectomy catheter was received by our product evaluation laboratory for a full examination.The report of balloon issue was confirmed.As received, the balloon and distal winding were found to be completely detached and not returned.The proximal windings were found unraveled.No visible damage was found from catheter body.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." and "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".An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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.

Event Description

As reported, during inflation test before use in patient of this fogarty embolectomy catheter, the balloon burst.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was available for evaluation.As per product evaluation findings, the balloon and distal windings were found to be completely detached and missing.

Manufacturer Narrative

Updated: h6 (investigation findings, investigation conclusions).Added: h6 (type of investigation).Further investigation was performed by the engineers in the manufacturing site.The manufacturing process have the controls to detect conditions related to balloon or windings, in which the general appearance of the catheter is verified.The units go through a final visual and inflation inspection process.The appearance of the catheter body is verified, and it should not have bends, wrinkles, cuts, contamination, stains or discoloration or ripples.Also, the windings of the balloon are inspected, for conditions such as loose windings or strands, separations, contamination, slipped, defective, exposed shoulder and / or excess adhesive.The balloon is inflated with the air capacity specified and both ends are inspected for conditions such as eccentricity, exposed cones, clear lines or contamination.Based on the available information there is no evidence that supports or confirms theses failure modes are associated to a manufacturing or 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: 18326187
• MDR Text Key: 330495560
• Report Number: 2015691-2023-18352
• 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: 02/06/2024

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 Operator: Health Professional
• Device Model Number: 120404FP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/06/2024
• 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