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U.S. Department of Health and Human Services

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

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COOK INC CODA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tachycardia (2095); Rupture (2208); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Citation: baikoussis, nikolaosg, et al. ¿aortic rupture during endovascular repair of a postoperative coarctation pseudoaneurysm in an adult: emergency lifesaving stent graft implantation. ¿ annals of cardiac anaesthesia, vol. 22, no. 2, 2019, p. 225, 10. 4103/aca. Aca_36_18. Accessed 31 dec. 2019. (b)(6). (b)(4). 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 that after the attempted use of a cook coda balloon, a male patient experienced an aorta rupture. A (b)(6) year old patient with a history of open surgery for an aortic coarctation was undergoing an endovascular aortic repair of an anastomotic pseudoaneurysm. The coda balloon was positioned inside a previously deployed thoracic stent and filled using a 20 ml syringe filled with contrast media and saline. Immediately after filling with the syringe, the patient experienced an aorta rupture and presented an acute worsening tachycardia, systolic blood pressure < 60 mmhg, and hypoxia, requiring emergency intubation. An emergency angiogram showed extravasation of the contrast media in the left hemithorax after the origin of the left subclavian artery (lsa) at the level of the proximal surgical anastomosis. The patient was then treated successfully with a second endograft positioned more centrally in the aortic arch with full coverage of the (lsa) orifice. An angiogram was performed showing no filling of the pseudoaneurysm sac and no more contrast media extravasation. The patient was transferred to the icu and a left hemithorax drainage tube inserted. After stabilization and extubation of the patient, a new ct angiography was performed confirming the sealing of the aortic rapture without contrast media extravasation and no evidence of any kind of endoleak. The patient¿s clinical condition rapidly became "uneventful" and he was transferred to the cardiac surgery department 3 days later with no neurological symptoms and no signs of left arm ischemia, so no left carotid lsa bypass was performed. Finally, the patient was dismissed from the hospital 10 days after the operation in good shape with no neurological or other kinds of complication. A 30-day postoperative follow-up with a new ct scan also showed normal stent-graft patency, no endoleak, and total thrombosis of the pseudoaneurysm with a diminished diameter. No other adverse effects have been reported for this incident.

 
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Brand NameCODA BALLOON CATHETER
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC.
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9535918
MDR Text Key186679343
Report Number1820334-2019-03168
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCY
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE,OTHER,USER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/31/2019 Patient Sequence Number: 1
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