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

Model Number 12A0602F

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

One 12a0602f catheter was returned for examination.The reported event of "a metal piece from the catheter body sticking out of catheter" was confirmed.As received the balloon latex and distal balloon windings were not returned.A cutdown of the proximal winding found no latex under the winding.The spring tip in the catheter body was fully stretched.Adhesive was not visible at the end of the spring.The proximal balloon windings appeared to be in good condition without any damage or abnormality.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.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 thrombolysis, distal emboli or blood clots or arteriosclerotic plaque, air emboli, aneurysms, arterial spasms, arteriovenous fistula formation, membrane separation and distal embolization.Exposure to the atmosphere, handling during insertion, and plaque and other deposits within the blood vessel may cause latex membrane degradation.In this case the latex membrane was torn in a way that allowed the spiral cable to be exposed.There is a possibility of vessel damage if the spiral cable is outside of the latex membrane and possibly in contact with the vessel.It should be note that the ifu indicates that "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.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, when pulling this fogarty catheter out of the artery, the catheter unsheathed leaving a metal piece from the catheter body sticking out of catheter.There was no allegation of patient injury.The device was available for evaluation.Patient demographics were unable to be obtained.

• 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
• 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: 10901406
• MDR Text Key: 220976759
• Report Number: 2015691-2020-14698
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PREAMENDMENT
• 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: 11/04/2020

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: 07/01/2021
• Device Model Number: 12A0602F
• Device Catalogue Number: 12A0602F
• Device Lot Number: 62086601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2019
• 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