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U.S. Department of Health and Human Services

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

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COOK INC CODA LP BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Model Number N/A
Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. Concomitant products: lombard medical aortfix; gore excluder leg (qty. 2); gore dryseal sheath (12fr); medtronic reliant balloon catheter. 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 a coda lp balloon catheter was unable to be inflated during an evar procedure, potentially due to a hole in the balloon material. In order to treat the patient's aortic aneurysm, a competitor graft was placed below the arteries along with one competitor leg graft in each iliac artery. Ballooning was initially attempted with another device unsuccessfully, which is reported under mfg. Report reference #: 1820334-2020-01328. Consequently, ballooning was attempted again with this device. The device was inserted through a competitor 12fr. Sheath to seal the proximal neck, junction of the leg, and the distal sealing site. During advancement of the balloon, the physician felt slight resistance at the femoral area, which was confirmed to have calcification. The physician advanced the balloon into the target site and attempted to inflate the balloon, but found that the device was unable to be inflated. Following two failed ballooning attempts with two separate devices, the physician advanced the sheath into one of the deployed leg grafts to avoid the calcification (as the physician attributes the failed attempts to the calcification). A competitor balloon catheter was placed into the sheath and the target sites were successfully sealed. The procedure was able to be completed with no adverse effects to the patient.
 
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Brand NameCODA LP 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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10298794
MDR Text Key241617784
Report Number1820334-2020-01329
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K150970
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCODA-2-9.0-35-120-32
Device Lot Number13197071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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