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

Model Number 12TLW805F35

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Patient demographics unable to be obtained.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.One fogarty catheter was received by our product evaluation laboratory for a full examination.Examination of the returned catheter found that the balloon was found to be ruptured in the middle area.Rupture edges did not appear to match up.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.See specification table".Through lumen was patent without any leakage or occlusion.No other visible damage or abnormality was observed from catheter body or windings.An engineering investigation will be performed in order to consider any potential factors that may have contributed to this complaint.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

A fogarty catheter from model nr.12tlw805f35 was received by our evaluation laboratory.As per visual inspection upon receipt the balloon seems to be damaged.No more information available.

Manufacturer Narrative

Added information to section h6 (type of investigation) updated section h6 (investigation findings) and h6 (investigations conclusions).Based on further engineering investigation, as part of the manufacturing process, the units go through a balloon inspection process including visual inspection in which the integrity of the catheter and balloon are validated.Also, a final inspection is performed.Additionally, as per specification for catheters produced by edwards lifesciences it is specified that the deterioration is a condition usually caused by age, excessive exposure to light, atmosphere, or ozone that appears on the balloon surface as a maze of fine cracks or crazing.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.

• 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: 17264988
• MDR Text Key: 318551539
• Report Number: 2015691-2023-14363
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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 Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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