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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 Extravasation (1842); Hematoma (1884); Tachycardia (2095)
Event Date 12/11/2020
Event Type  Injury  
Manufacturer Narrative

Date of event: event occurred sometime between january 2009 and march 2019. Suspect medical device: unknown 32-mm cook coda balloon catheter. Reporter occupation: unknown. Citation - moulakakis kg, lazaris am, kakisis jd, et al. "aortic rupture during endovascular aneurysm repair. " report of our experience and review of the literature. Aorta (stamford). 2020;8(4):98-103. Doi:10. 1055/s-0040-1714123. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

The below description of a serious injury using an unknown cook 32-mm coda balloon catheter was taken from the following article: moulakakis kg, lazaris am, kakisis jd, et al. "aortic rupture during endovascular aneurysm repair. " report of our experience and review of the literature. Aorta (stamford). 2020;8(4):98-103. Doi:10. 1055/s-0040-1714123. The following was stated in the article: "a (b)(6)-year-old man underwent elective evar for a 6. 2-cm infrarenal saccular aaa. His past medical history included chronic obstructive pulmonary disease, arterial hypertension, and hostile abdomen due to previous abdominal operations (peritonitis because of small bowel perforation, gastrectomy, and large incisional hernia). Regarding the characteristics of the aaa, there was calcification in the proximal neck (diameter of the neck 19 mm and length 3 cm), and the aorta at the level of the bifurcation was 16 mm in diameter and calcified (fig. 3a, b). " "an aortouniliac endograft 22 mm in diameter (cook, (b)(4)) was deployed 1 cm below the left renal artery, intending to avoid the calcified plaque, and sealed in the left common iliac artery, while an occluder plug was inserted into the right common iliac artery. Low-pressure ballooning was performed manually with a coda 32-mm balloon catheter (cook, inc. , (b)(4)) in the area of the most proximal covered stent and the distal fixation sites, as well as in the overlap zones between the main body and the iliac limbs. The final angiography revealed a type 1a endoleak, which was attributed to calcification of the infrarenal neck leading to poor apposition of the endograft. Multiple attempts to balloon the proximal neck were performed (with inflation volumes of less than 25 cc), and the patient developed a drop in blood pressure. " "in the intra-operative angiography, an ¿ulceration bulge¿ of the aortic neck was observed without extravasation. A cuff was placed just below the lowest left renal artery covering the bulging area of the aorta. The patient was hemodynamically stable and the procedure was completed with a femoral-femoral bypass. " "two hours later, while the patient was in the recovery room, he developed tachycardia, emergency ct angiography was performed, which revealed a local contained extravasation around the proximal neck of the aorta. The patient was transferred to the operating room; through a rooftop approach with a left-side visceral rotation the proximal aortic neck was exposed. A local hematoma was found with no active hemorrhage (fig. 3c, d). Biological glue was applied, and the abdomen was closed. In the postoperative course, the patient developed atrial fibrillation and depressed pulmonary function. " "he was discharged on postoperative day 19 in good general condition. At 1-year follow-up, a ct scan showed no evidence of endoleak and complete exclusion of the aneurysm (fig. 3e¿g). " no other adverse effects were 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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12084323
MDR Text Key259157461
Report Number1820334-2021-01627
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/29/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/29/2021 Patient Sequence Number: 1
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