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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 G03831
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/23/2018
Event Type  Death  
Manufacturer Narrative

Concomitant medical products: gore excluder stent graft. Tscmg-35-260-7-les-jp guidewire. The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.

 
Event Description

It was initially reported on (b)(6) 2018, a (b)(6)-year old female patient underwent stent graft placement to treat thoracic aortic aneurysm (taa) / abdominal aortic aneurysm (aaa). After another manufacturer's stent graft was placed below renal artery, touch-up ballooning was performed with coda balloon. The proximal platinum marker of the coda balloon was located at the proximal end of the stent graft during inflation. No part of the balloon was outside of the graft during inflation. At this point, the infrarenal abdominal aorta ruptured blood infusion was performed, but the patient's hemodynamic stability was not recovered. They attempted to place another stent graft was attempted to treat the abdominal aorta damage, but this attempt failed. Therefore, the procedure was converted to open surgical repair. The patient was not recovered, and deceased. As reported, the patient has severe calcification from the abdominal aorta through the iliac artery. The balloon was inflated using a 20cc syringe. However, the volume/pressure used during inflation is not known. It is not known if the patient was on anticoagulants. An autopsy will not be performed. The device will not be returned to aid in the investigation as the event was not related device defect.

 
Manufacturer Narrative

Investigation ¿ evaluation: the coda balloon device was not returned for an analysis and no photos or imaging were provided. Without the complaint device, a physical investigation was not able to be completed. A document based investigation has been performed which includes a review of complaint history, the device history record, the instructions for use, manufacturing instructions, and quality control data. A review of the device history record (dhr) for lot 9088439 showed there were no non-conformances that would have caused or contributed to this incident. A complaint history records review revealed this is only reported complaint associated with complaint lot number 9088439. The complainant did not return the complaint device to cook for investigation. No autopsy report or imaging was provided. The volume used for inflation was not provided. It was reported there was severe calcification from the abdominal aorta through the iliac artery present. The physician also commented that ¿it is possible that the calcification within aorta and ballooning against stent graft may have impacted for aortic damage. ¿ however, based on the available information, the definitive cause for the reported event cannot be determined. The appropriate cook personnel have been notified of this event. Per the quality engineering risk assessment, no further action is warranted. Monitoring will continue to be performed for similar complaints.

 
Event Description

There has been no new information received since the last report was submitted.

 
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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 Key8126988
MDR Text Key129146537
Report Number1820334-2018-03465
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK032869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG03831
Device Catalogue NumberCODA-2-9.0-35-120-32
Device LOT Number9088439
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/13/2018
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: 12/03/2018 Patient Sequence Number: 1
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