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

Model Number 120803FSP

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Nevertheless, an image was provided, therefore and image evaluation was performed.The spring tip, distal winding and balloon were separated and not visible in the provided picture.In addition, proximal winding was unraveled.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 testing prior to use in the same procedure of two fogarty embolectomy catheters, the balloon burst, leading to tip and metal spring separation in one device (medwatch # 32304) and leading to balloon separation leaving exposed the metal spring attached to the catheter body in the other one (medwatch # 32303).Patient demographics not available.There was no allegation of patient injury.The devices were not available for evaluation since they were discarded.

Manufacturer Narrative

Updated: h6 (component code, impact code, clinical code, device code, investigation findings, investigation conclusions) added: d4 (expiration date), h4 (device manufacturer date).Based on further investigation performed by the engineers in the manufacturing site.As per image provided by the customer, 'metal spring separation in one device' was confirmed.However, there is no evidence that supports or confirms that either failure mode is associated to a manufacturing or design defect.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Additionally, as part of the manufacturing process, all units go through a balloon inflation and visual inspection.Per the instruction for use (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'.

• 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: 17180616
• MDR Text Key: 317639005
• Report Number: 2015691-2023-14119
• 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: 08/04/2023

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 Operator: Health Professional
• Device Model Number: 120803FSP
• Device Catalogue Number: 120803FSP
• Device Lot Number: 64344778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2022
• 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