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

Model Number 120805F

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

There were two potential lot numbers identified: - lot 64677337: (h4) device manufacturer date 2022/11/12; (d4) expiration date 2025/02/07 - lot 64936888: (h4) device manufacturer date 2023/04/12; (d4) expiration date 2024/07/05 patient demographics unable to be obtained.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.As part of the manufacturing process, the units go through balloon integrity inspection process.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.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.H3 other text : device not returned to manufacturer.

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 2023-24482-01).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 2023-24483-01) 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

Added information to section a2, a3.A4, h6 (type of investigation) updated section h6 (device code), h6 (investigation findings) and h6 (investigations conclusions).H3: finally, one fogarty catheter was received for evaluation.The report of "catheter detached" was confirmed.However, balloon was not burst.The balloon was received completely detached from catheter body, straight edge on the proximal end of balloon latex suggested the balloon latex was intact.The windings were found to be completely detached and not returned.No visible damage was found from catheter body.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.The manufacturing process includes controls to detect conditions related to balloon or windings.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".

• 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; stated rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 18391831
• MDR Text Key: 331293740
• Report Number: 2015691-2023-18754
• 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: 03/05/2024

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: 64677337 / 64936888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 116 KG