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

Model Number 120804FP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

One fogarty catheter was received by our product evaluation laboratory for a full examination.Customer report of "balloon completely detached from the catheter" was confirmed.The balloon was found to be completely detached and not returned.Both proximal and distal windings were found unraveled.No other visible damage was found from the catheter body.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 and pull force for each size catheter.See specification table." a supplemental report will be submitted accordingly upon investigation completion.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.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 use in patient of this fogarty embolectomy catheter, the catheter balloon was completely detached from the catheter.The balloon was recovered in the same procedure with no evidence of residual balloon pieces remaining in patient.No additional intervention was needed and there was no allegation of patient injury.The device was available for evaluation.Patient demographics unable to be obtained.

Manufacturer Narrative

Updated section h6 (investigation findings) and h6 (investigations conclusions).Based on the available information there is no evidence that supports or confirms that the failure modes found are associated to a manufacturing or design defect.The manufacturing process has the controls to detect the found conditions.

• 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: 17744190
• MDR Text Key: 323383418
• Report Number: 2015691-2023-15917
• 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: 11/06/2023

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: 120804FP
• Device Lot Number: 64354890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2023
• 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