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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a thoracic endovascular aortic repair procedure, a coda balloon catheter was inflated with triply diluted contrast media with appropriate pressure amount but ruptured inside the stent graft at third inflation.No endoleak was found, so the procedure was completed without using another balloon catheter.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, trends, and quality control of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) which detail the indications for use, contraindications, warnings and precautions.Based on the information provided, no product returned and the results of our investigation factors that may have contributed to the balloon rupture may be related to the user not following labeling instructions as it relates to balloon placement and/or pressure; however, this cannot be conclusively determined.Per the ifu, the physician must always manipulate the catheter using fluoroscopic control in order to use the radiopaque markers to ensure that the entire balloon is positioned within the prosthesis and to adhere to balloon inflation volume parameters outlined in the ifu.If the balloon is partially outside of the graft, the pressure of the balloon can increase in certain areas, potentially allowing the balloon to burst.The physician must also inflate the balloon to the appropriate volume within the graft.The graft used in this procedure was an esbe-28-80-t-pf.The diameter of the balloon should not have been inflated to much more than the 28 mm of the diameter of the graft; this would equate to approximately 18 cc, according to the balloon inflation parameters in the ifu.If it was inflated more than this, the balloon could rupture.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6342965
• Report Number: 1820334-2017-00171
• Device Sequence Number: 543862
• Product Code: DQY
• UDI-Device Identifier: 00827002530256
• UDI-Public: (01)00827002530256(17)190727(10)7150943
• Combination Product (Y/N): N
• PMA/510(K) Number: K032869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: N/A
• Device Catalogue Number: CODA-2-10.0-35-120-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1