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

Catalog Number CODA-2-9.0-35-120-32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Dissection (2491)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant products: excluder stent/graft by gore medical.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an endovascular aneurysm repair (evar) was performed.The stent graft used in the procedure was made by another manufacturer.After the deployment of the other manufacturer's stent graft, a type ia endoleak was visible.A coda balloon was used as to perform touch-up ballooning at the proximal site of the stent graft.During touch-up ballooning, a dissection occurred near the left renal artery.It was reported that touch-up ballooning was sometimes conducted while the balloon protruded from the stent graft.No additional treatments were performed for the dissection, and this medical case got a follow-up examination.Additional information has been requested.At the time of this report no additional details are available.

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported in additional information provided on 28may2019, that when the physician used a coda balloon during the evar + ibe procedure, it protruded from the main body a bit.The physician had never experienced the dissection of the proximal side of the zenith before, but stated that, "i should have been a bit more careful about the existence of suprarenal stents when i conducted touch-up ballooning." the physician does not think that coda-2-9.0-35-120-32 contributed to the incident.There were no problems noted with the access route.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.H6 method code: device not accessible for testing (4117).Investigation - evaluation a review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device and imaging were not available for return.However, a similar complaint experiencing a similar failure mode was referenced (mfg.Report reference #: 1820334-2017-04257).The image review found "the balloon was deflated, reflated, and advanced back to its position in the distal descending thoracic aorta.However, inflation continued beyond the volume that the original coda was inflated to.The balloon's shape changed from the shape of tube to round, indicating that aortic wall had ruptured.The balloon ruptured upon further inflation to a diameter of 42mm." the investigation conclusion was attributed to patient condition and procedure related.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file showed that the affected product is safe and effective for its intended use.A review of the device history record for lot 9579400 found zero nonconformances that could have contributed to the failure mode.It should be noted that there are no additional complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use "the coda and coda lp balloon catheters are intended for temporary occlusion of large vessels, or to expand vascular protheses." warnings "do not exceed maximum inflation volume.Adhere to balloon inflation parameters as shown in fig.1.Over inflation of balloon may result in: damage to vessel wall and/or vessel rupture.Rupture of balloon.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.When used to expand a vascular prothesis, the balloon radiopaque markers should remain within the prosthesis." potential adverse events "vessel dissection, perforation, rupture or injury¿.Instructions for use balloon preparation."note: balloon and balloon lumen of the coda and coda lp balloon catheters contain air.The air must be removed from balloon and balloon catheter prior to insertion using standard technique.2.Prepare balloon lumen with standard 3:1 saline and contrast mixture as follows: a.Attach syringe, with appropriate amount of 3:1 saline and contrast mixture, to stopcock on balloon lumen.B.Purge all air from balloon in standard fashion.C.Completely deflate balloon and close stopcock." balloon introduction and inflation."2.Advance the balloon catheter over a pre-positioned.035 inch wire guide, utilizing a minimum 14.0 french introducer sheath for the 10.0 french coda balloon catheter or a minimum 12.0 french introducer sheath for the 9.0 french coda lp balloon catheter.Note: if resistance is met while advancing the wire guide or balloon catheter, determine the cause and proceed with caution.Caution: prior to introduction, determine the amount of standard 3:1 saline and contrast mixture needed to inflate the balloon to the desired inflation diameter.Refer to the balloon inflation parameters chart in fig.1.Over-inflation of the balloon may result in damage to the vessel wall and/or vessel rupture.3.Under fluoroscopy, advance the balloon to the desired position using radiopaque markers.Caution: if the coda or coda lp balloon catheter is being utilized to expand a vascular prothesis, use the radiopaque markers to ensure that the entire balloon is positioned within the prothesis.4.Inflate balloon with standard 3:1 saline and contrast mixture using 20 cc or larger syringe.Adhere to the recommended balloon inflation volumes." based on the information provided, no returned product, and the results of our investigation, a definitive root cause can be attributed to a component failure due to user error and a failure to follow instructions.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event description information to report at this time.

• 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: 8655871
• MDR Text Key: 146621948
• Report Number: 1820334-2019-01369
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K032869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: CODA-2-9.0-35-120-32
• Device Lot Number: 9579400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR