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

Model Number 120602F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2023

Event Type  malfunction  

Manufacturer Narrative

The catheter was received by our product evaluation laboratory for a full examination.As received, the spring tip was stretched.The balloon was found to be completely detached and not returned.Distal windings were found unraveled.Proximal windings were not returned.No other visible damage was found from catheter body.As per instructions for use (ifu) review "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.".

Event Description

As reported, during a left arm thrombectomy with this fogarty catheter, the tip broke remaining inside the patient (medwatch #30548).Another fogarty catheter was used and the tip also broke remaining inside the patient (medwatch #31896).Investigation ongoing.The devices were available for evaluation.

Manufacturer Narrative

Corrected data: added information to section d4 (expiration date) and h4 (device manufacturer date) updated section h6 (component code), h6 (impact code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion) 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.The information was inadvertently omitted from the earlier report but it does not change the event, outcome, or conclusions previously submitted.

• 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 Contact: samantha evenleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17142347
• MDR Text Key: 317307478
• Report Number: 2015691-2023-13922
• 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: 09/06/2023

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: 120602F
• Device Catalogue Number: 120602F
• Device Lot Number: 64743402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2022
• 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