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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 Death (1802); No Code Available (3191)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative

This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

On (b)(6) 2019 an internal device tracking report was received which contained information that a patient death had occurred. A list of devices implanted on (b)(6) 2019, was provided in the report. Devices listed on the report: tffb-22-82-zt, lot# 9171116; zsle-11-90-zt, lot# 7589621; zsle-11-74-zt, lot# 9172498; esbe-24-58-zt, lot# 7530242. In response to a follow up. Request for additional information, the physician stated that her death was not directly related to the device. During the initial surgery, they did over-balloon the device, which caused a small tear in the aorta, but were able repair that immediately. The patient was brought back for a secondary surgery to repair bleeding in the groin, which resulted from the closure device used, and not related to the cook endografts. During this surgery, the patient suffered multiple cardiac events, which the doctor believes was the cause of the ischemic bowel event that lead to the patient's death.

 
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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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8484358
MDR Text Key140956850
Report Number1820334-2019-00763
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK032869
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/03/2020
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
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 Received04/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/03/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/04/2019 Patient Sequence Number: 1
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