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

Model Number 120804F

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that during use in patient with a fogarty arterial embolectomy catheter, the balloon fell off in the blood vessel.¿the balloon did not break but it fell off.The balloon was picked out with a new catheter¿.Follow up indicated that the staff used a new catheter to pick out the balloon that had fell off in the vessel.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

One 120804f fogarty catheter was returned for examination.The reported event of balloon issue was confirmed.The catheter body was broken at the proximal end of the proximal balloon windings.The edges at the break locations appeared to match.Part of the proximal balloon windings had unraveled but remained attached.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." both the balloon latex and distal balloon windings were intact.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Per the instructions for use, 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.To minimize the risk of vessel or membrane damage, the maximum recommended pull force for the catheter should not be exceeded.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.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.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 9871768
• MDR Text Key: 195707256
• Report Number: 2015691-2020-11104
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 120804F
• Device Catalogue Number: 120804F
• Device Lot Number: 62625270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/06/2020; 07/23/2020
• Supplement Dates FDA Received: 04/16/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR