MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY OCCLUSION CATHETER; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 62080822F

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

The device was discarded by the customer.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can a root cause or any potential contributing factors be identified.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The maastricht 3 organ donor procedure, is known as a non-heart-beating donation (nhbd) procedure.Depending on the type of maastricht 3 procedure that is being performed, occlusion catheters may be used to occlude vessels.In this case, the customer stated that the balloon did not maintain its inflation and it was believed that there was a hole in the balloon.In the event that the balloon of the catheter does not maintain its inflation during organ harvesting, it is possible that the procedure will have to be aborted.Additional information regarding this specific case and procedure was unable to be obtained.It is unknown if user or procedural factors affected the outcome of this procedure.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.(b)(4).

Event Description

It was reported that during a maastricht 3 organ donor procedure, the balloon on the fogarty catheter did not remain inflated.The initial radiological examination performed noted an occlusive balloon in addition to the diaphragm.The lower half of the organ donor (abdomen and legs) was perfused.The upper half of the organ donor (thorax, arm, and head) was not perfused.After several minutes, the upper part of the organ donor recolored and a pulse was perceived at the carotid.A subsequent radiological examination noted no balloon; thus, the organ harvesting procedure was canceled.It was confirmed that the balloon had a hole and was "dead".The device was discarded and not available for return.

• Brand Name: FOGARTY OCCLUSION CATHETER
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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 ; one edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7208521
• MDR Text Key: 98187083
• Report Number: 2015691-2018-00226
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: 62080822F
• Device Catalogue Number: 62080822F
• Device Lot Number: 60832785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2017
• 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