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

Model Number	G53024
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an (b)(6) male patient underwent an endovascular aneurysm repair (evar).After placing a stent graft, the coda balloon catheter was inserted into the patient by left approach for touch-up ballooning just above the bifurcation of the left common iliac artery (cia) and iliac artery aneurysm (iia).The balloon ruptured during touch-up, so another (b)(4) balloon was used instead.There have been no reports of any adverse effects to the patient.Additional patient anatomy, procedure and device usage details have been requested, but no response has been received at the time of this report.
Additional Manufacturer Narrative
Additional information received on february 1, 2018.Investigation/evaluation: the actual complaint device was returned and a visual inspection was performed.A review of the device history record, complaint history, drawings, instructions for use, and quality control data was also conducted.Information about the ballooning part of the procedure such as technique and resistance felt was requested and provided.The pressure and volume of balloon inflation was reported as unknown because the physician "inflated the balloon on his feel with watching the fluoroscope screen".A medtronic endurant was used for this procedure.Imaging and the sizing chart are not available.It was unknown if the patient was on anticoagulants.The device was returned and underwent a device failure analysis to verify that relative specifications were passed.This device's balloon bonds were found to be within specification and the catheter was found to be free of damage.It was noted that the balloon burst circumferentially, therefore a leak test was not performed.The device history record was reviewed and noted no nonconformances related to the reported failure mode.The quality control specification and design history files were reviewed and no evidence was found that the device was manufactured out of specification.A review of complaint history records revealed this complaint to be the only reported complaint associated to the complaint lot number 8295168.Each device is shipped with instruction for use (ifu) listing the indications for use, contraindications, warnings and precautions.Per the ifu, upon removal from package, inspect the product to ensure no damage has occurred.Do not exceed maximum inflation volume.Rupture of balloon may occur.The balloon is constructed of heat-sensitive material.Do not heat or attempt to shape the catheter tip.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate balloon.Caution: if the 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.The maximum inflation volume listed in the ifu for this device is 34 cc's.Balloon rupture can be caused by over-inflation, pulling on the balloon while inflated, patient vessel calcification, or inflating the balloon partially outside of a vascular prosthesis.The response to additional questions was that calcification existed and was contained outside of the graft.It was also stated that no resistance was felt while advancing the balloon but that the balloon was partially outside of the graft when inflated.If the balloon was inflated outside the sealing zone, it increases the likelihood that the balloon will rupture through contact with the external stent or calcification.Based on the available information, the likely reason for the failure is product use or handling related: did not follow instructions.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.
Event or Problem Description
The calcification was contained outside of the graft.No resistance was felt while advancing the balloon.A part of the balloon was outside the graft when being inflated.The saline to contrast ratio was 1:1 ~ 1:2.The inflation volume could not be determined because the physician inflated the balloon on his feel with watching the fluoroscope screen.

• Brand Name: CODA BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7199264
• Report Number: 1820334-2018-00012
• Device Sequence Number: 1486529
• Product Code: DQY
• UDI-Device Identifier: 00827002530249
• UDI-Public: (01)00827002530249(17)201016(10)8295168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: G53024
• Device Catalogue Number: CODA-2-10.0-35-120-32
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2017
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR