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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 G36042
Device Problems Leak/Splash (1354); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2015
Event Type  Malfunction  
Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.

 
Event Description

The complainant reported that a leakage was found in the coda balloon catheter during the procedure. It was further noted that there was a split in the entire length of the balloon. There were no reported serious injuries to the patient as a result of the product problem.

 
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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 Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7596871
MDR Text Key111456258
Report Number1820334-2018-01798
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,OTHER,USE
Reporter Occupation
Type of Report Initial
Report Date 06/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG36042
Device Catalogue NumberCODA-10.0-35-100-32
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2014
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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