MAUDE Adverse Event Report: COOK INC CODA LP BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G03831

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The area representative reported a patient with a symptomatic abdominal aortic aneurysm (aaa) underwent an endovascular aneurysm repair (evar).The physician was preparing to place another manufacturer's graft and using the coda lp balloon catheter near the renal arteries to stop the blood flow in the aorta.It was reported that four coda lp balloon catheters would not hold enough pressure to stop the blood flow.A fifth coda lp balloon catheter was used and the other manufacturer's graft was placed successfully.The patient was discharged from the hospital.As reported there was no harm to the patient.No unintended portion of any of these devices was left in the patient¿s body.There were no additional procedures required due to the reported issues.There has been no adverse effect to the patient resulting of the reported device issues.The complaint devices were thrown away and will not be returned for evaluation.Manufacturer report numbers 1820334-2017-03499 (coda lp balloon, lot 8007270), 1820334-2017-03781 (coda lp balloon, lot 8007270), 1820334-2017-3500 (coda lp balloon, lot 7083872), and 1820334-2017-03501 (coda lp balloon, unidentified lot) have been filed to capture the each of the four balloons that would not hold pressure.

Manufacturer Narrative

Investigation ¿ evaluation: the coda balloon device was not returned.No photograph or imaging was provided for review.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed.A review of complaint history, the device history record, drawings, instructions for use, and quality control data was conducted.Qc specifications, drawings and design verification files were reviewed.Balloon certificate of compliance indicates that all of the devices were 100% visually inspected.Balloon pressure tests and burst tests were performed and no evidence was found that the device was manufactured out of specification.The device history record was reviewed and no non-conformances were noted.A review of complaint history records was performed and revealed this is the only complaint received associated with the complaint lot number 8007270.Each coda balloon device is shipped with the instructions for use (ifu), which specifies the maximum balloon inflation volume and provides instructions on balloon preparation, inflation, deflation and withdrawal.Per the ifu: upon removal from package, inspect the product to ensure no damage has occurred.If a coda balloon catheter is being utilized to expand a vascular prosthesis, use the radiopaque markers to ensure that the entire balloon is positioned within the prosthesis.Inflate balloon with standard 3:1 saline and contrast mixture using a 20cc or larger syringe.Adhere to recommended balloon inflation volumes.If balloon pressure is lost and/or balloon rupture occurs, deflate the balloon and remove balloon and sheath as a unit.Warnings: do not exceed maximum inflation volume.Rupture of balloon may occur.Adhere to balloon inflation parameters as shown in fig.1.Do not use a pressure inflation device for balloon inflation.Do not use a power injector for injection of contrast medium through distal lumen.Rupture may occur.Precautions: use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate balloon.Balloon and balloon lumen of the coda balloon catheter contain air.The air must be removed from balloon and balloon catheter prior to insertion using standard technique.Based on the information provided, and without the complaint device, a definitive root cause could not be determined.The root cause for this complaint is inconclusive.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.

• Brand Name: CODA LP BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7037743
• MDR Text Key: 92935679
• Report Number: 1820334-2017-03499
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002038318
• UDI-Public: (01)00827002038318(17)200621(10)8007270
• Combination Product (y/n): N
• PMA/PMN Number: K032869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G03831
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1