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

Model Number 12TLW805F35

Device Problems Deflation Problem (1149); Material Rupture (1546)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

As reported, before use in patient with this fogarty embolectomy catheter, the balloon 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 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

The fogarty catheter was sent to our product evaluation laboratory for a full evaluation.Customer report of 'balloon could not be deflated' was not able to be confirmed due to balloon condition as received.The balloon was found to be ruptured in the central area.The ruptured edges did not appeared to match at the ruptured location.No visible damage was observed from distal and proximal windings and catheter body and syringe.The through lumen was found to be patent and did not leak.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Per the 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 volume and pull force for each size catheter".

Event Description

As reported, before use in patient with this fogarty embolectomy catheter, the balloon could not be deflated.There was no allegation of patient injury.The device was received for evaluation.As per product evaluation findings, the balloon was found to be ruptured in the central area.The ruptured edges did not appeared to match at the ruptured location.

Manufacturer Narrative

Updated: (component code, investigation findings, investigation conclusions).Added: h6 (type of investigation).Further investigation was completed by the engineers in the manufacturing site.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect.Additionally, as part of the manufacturing process, units go through balloon and winding inspection process.

• 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: 18482477
• MDR Text Key: 332529067
• Report Number: 2015691-2024-00215
• 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,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 65069309
• 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: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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
• Patient Outcome(s): Other