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

Model Number 120404F

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Follow up has started to determine whether the device is available for evaluation, and an investigation will be completed to consider any potential factors that may have contributed to this complaint.The lot number for this device was not supplied; therefore, the related manufacturing records were unable to be reviewed.

Event Description

As reported, during removal from patient of this fogarty catheter through a trocar, approximately 2.5 cm catheter tip remained in the patient.This fogarty catheter was used for a percutaneous balloon decompressions of trigeminal ganglion, even though surgeons and hospital staff are aware that this is not the intended use of the edwards fogarty arterial embolectomy catheter.Nurse stated that the residual tip of embolectomy catheter remains in the patients brain, which could be confirmed after the patient underwent ct brain post operatively, and showed a small metallic fragment approximately 2.5 cm that remains insitu.Customer did not mention if there was any change in the patient's neurological status, but expressed that the patient had been experiencing pain.Customer confirmed that this product was not expired.Patient remains under treatment.Follow up has started for device return.

Manufacturer Narrative

Despite several attempts, the fogarty catheter involved in this case was not available for evaluation.Therefore, a product non-conformance or device failure could not be confirmed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Further investigation was completed by the engineers at the manufacturing site.Based on the available information, this product failure mode could be considered an off-label use issue.The ifu (instructions for use) was reviewed, and the contraindications section states that "the arterial embolectomy catheter should not be used outside the arterial system".Additionally, visual inspections are in place to prevent this type of malfunction in our manufacturing process.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

As per further review, the "health effect - clinical code" in h6 was updated.

• 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: 14616506
• MDR Text Key: 301195474
• Report Number: 2015691-2022-06074
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

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: 120404F
• Device Catalogue Number: 120404F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 07/07/2022; 07/07/2022
• Supplement Dates FDA Received: 07/07/2022; 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 86 YR
• Patient Sex: Female