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

Model Number 120805F

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

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.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 with this fogarty arterial embolectomy catheter, the tip broke off and ended up left in a patient.There was no allegation of patient injury.The device was available for evaluation.

Event Description

As reported, during a fistulogram procedure in an occluded fistula with no proximal flow, the balloon of this fogarty arterial embolectomy catheter burst and detached and ended up left in a patient (medwatch #39301; manufacturer reference (b)(4).It was difficult to identify the dislodge forgarty balloon but believed to be in the thrombosed cephalic vein.Multi consultant decision made not to stent the fogarty balloon dislodged tip or to remove with open surgery.The foreign body was left in situ.After this, a second fogarty embolectomy catheter (medwatch # 40993; manufacturer reference (b)(4) was used, and after the procedure, the balloon burst and detached.There was no allegation of patient injury.The devices were not available for evaluation.

Manufacturer Narrative

The device involved in this complaint was not available for evaluation.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Additionally, as part of the manufacturing process, the units go through balloon integrity inspection process.Furthermore, the inspection verifies the tip of the probe, to confirm if the hard tip condition is present or if the excessively soft tip condition is present.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.

Manufacturer Narrative

Added information to sections a2, a3a and a4 updated section h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).One catheter was received for full evaluation.The report of detached issue was confirmed.Balloon and windings were detached from catheter and the balloon and windings were not returned.No visible damage was observed from catheter body.The manufacturing process have the controls to detect conditions related to balloon and windings.Based on the available information there is no evidence that supports or confirms theses failure modes are associated to a manufacturing or design defect.The ifu was reviewed and it indicates "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".

• 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: 18182097
• MDR Text Key: 328671482
• Report Number: 2015691-2023-17633
• 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,Followup
• Report Date: 03/06/2024

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: 120805F
• Device Lot Number: 64936888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 02/15/2024
• Supplement Dates FDA Received: 12/26/2023; 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 116 KG