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

Model Number 120602F

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2023

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product an investigation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation results.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.

Event Description

As reported, this fogarty catheter has an unknown failure mode with harm or potential harm to the patient.No further information available.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date) updated section h6 (component code), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusion).Based on further engineering investigation, and it was confirmed that the manufacturing process has the controls to detect conditions related to balloon, windings or spring tip, in which the general appearance of the catheter is verified and also an aleatory balloon pull test is performed.As part of the manufacturing process the units go through a final visual and inflation inspection process and also the windings of the balloon are inspected.

Manufacturer Narrative

It was further informed that the catheter broke during left arm thrombectomy and the catheter tip remained inside the patient.Another fogarty catheter (medwatch # 31896) was used and the tip of the second catheter also broke remaining inside the patient.The investigation of the event is ongoing.Added information to section d4 (lot number) since the lot number was received.The catheter was received by our product evaluation laboratory for a full examination.The report of "tip broke" was confirmed.As received, the spring tip was stretched.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 catheter body.As per review of the intructions 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".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 a left arm thrombectomy with this fogarty catheter, the tip broke remaining inside the patient.Another fogarty catheter was used and tip also broke remaining inside the patient (medwatch # 31896).The investigation of the event is ongoing.

• 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: 16929860
• MDR Text Key: 315191959
• Report Number: 2015691-2023-12988
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• 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