MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHET; CATHETER, EMBOLECTOMY

Model Number 12TLW804F

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

One 12tlw804f catheter was returned for examination.The reported event of inflation difficulty was confirmed.The balloon was found to be ruptured.After relaxing, the latex ruptured edges did not appear to match up.Both the balloon windings were intact.No other visible damage was observed from the catheter.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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.To minimize the risk of vessel damage, balloon rupture, or tip detachment, the maximum recommended inflation volume and pull force for the catheter should not be exceeded.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.The instructions for use of the product contains the following statement: ¿as with all catheterization procedures, complications may occur.These may include local or systemic infection, local hematomas, intimal disruption, arterial dissection, perforation and vessel rupture, hemorrhage, arterial thrombosis, distal embolization of blood clots and atherosclerotic plaque, air embolus, aneurysm, arterial spasm, arteriovenous fistula formation, and balloon rupture with fragmentation, tip separation and distal embolization.¿ in this case, there was no allegation of patient injury.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

It was reported that during use in a patient of this fogarty catheter, the balloon could not be inflated.There was no allegation of patient injury.Patient demographics were unable to be obtained.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 11049848
• MDR Text Key: 224441708
• Report Number: 2015691-2020-15156
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

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 Expiration Date: 09/05/2021
• Device Model Number: 12TLW804F
• Device Catalogue Number: 12TLW804F
• Device Lot Number: 62290710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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