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

Model Number 62080822F

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

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 an organ removal procedure with this fogarty catheter, the placement of the catheter in the arterial cannula up to the sub-diaphragmatic was carried out without difficulty.However, after filling the balloon with 25 cc of contrast product, the personnel in charge of the procedure could not find the balloon during radiographic control.Upon removal of the catheter, a burst balloon was noted.A second catheter with the same reference and the same lot number was used to alleviate the incident; however, after 45 minutes of use, the balloon burst.A third catheter of the same reference and the same lot number was used but the balloon also bursts causing the procedure to be stopped and the loss of several grafts.Attempts are being made for patient status and demographics.

Manufacturer Narrative

A phone call was placed between the director of product safety and the hospital regarding this event of balloon burst during an organ transplant procedure.It was indicated during this phone call that during an organ removal procedure with this fogarty catheter, the placement of the catheter in the arterial cannula up to the sub-diaphragmatic was carried out without difficulty.However, after filling the balloon with 25cc of contrast product and being inflated about 90 minutes, the personnel in charge of the procedure does not find the balloon during radiographic control.Upon removal of the catheter, a burst balloon was noted.A second catheter with the same reference and the same lot number was used to alleviate the incident; however, the balloon burst immediately after inflation.A third catheter of the same reference and the same lot number was then used but the balloon also burst within 60 minutes causing the procedure to be stopped and the loss of several grafts in perfect condition.Additionally it was indicated that the contrast agent used to inflate the balloon, xenetix 300.According to the ifu of this agent, the active substance of xenetix is iobitridol.100 millilitres (mls) of solution for injection of xenetix 300 contains 65.81 g of iobitridol, corresponding to a quantity of 30 g of iodine.The other ingredients are: sodium calcium edetate, trometamol, trometamol hydrochloride, water for injection, sodium hydroxide or hydrochloric acid.

Manufacturer Narrative

One 62080822f fogarty catheter with a non-ew device was returned for examination.The reported event of "a burst balloon was noted " was confirmed.The balloon was ruptured between the windings.The edges of the ruptured latex did appear to match.Per the ifu "to minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume for each size catheter (see specification table).Exposure to calcified plaque within the vessel may increase the possibility of balloon rupture.".Both balloon windings were intact.No other visible damage was observed from the catheter.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The fogarty occlusion catheters are indicated for temporary vessel occlusion.Per the ifu: balloon rupture and catheter separation are the most frequent causes of failure for vascular catheters.The possibility of balloon rupture must be taken into account when considering the risks involved in any occlusion procedure.To minimize the risk of vessel damage, balloon rupture, or tip detachment, do not exceed the maximum recommended inflation volume for each size catheter.Exposure to calcified plaque within the vessel may increase the possibility of balloon rupture.Lastly, the ifu recommends: use of a highly viscous or particulate contrast medium is not recommended for balloon inflation because the inflation lumen may become occluded.This case involved a maastricht iii organ harvesting procedure in which the balloon ruptures caused the loss of three organ grafts.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.No corrective or preventative action will be taken at this time.Related medwatchs for this event 2015691-2020-11662 and 2015691-2020-11663.

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 9993110
• MDR Text Key: 189063623
• Report Number: 2015691-2020-11661
• Device Sequence Number: 1
• Product Code: MJN
• 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,Followup
• Report Date: 03/31/2020

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: 09/23/2021
• Device Model Number: 62080822F
• Device Catalogue Number: 62080822F
• Device Lot Number: 62331523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/24/2020; 04/24/2020; 07/23/2020
• Supplement Dates FDA Received: 05/06/2020; 05/14/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 65