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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS

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COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTA3-14-90-3-4
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2018
Event Type  malfunction  
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
It was reported, the advance micro¿ 14 ultra low-profile pta balloon catheter was found frayed prior to a peripheral arteriogram procedure. The frayed device was noted while on the preparation table. A second balloon device was used to complete the procedure successfully. No adverse effects have been reported regarding this incident.
 
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Brand NameADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA 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 Key7773357
MDR Text Key116869238
Report Number1820334-2018-02336
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/11/2021
Device Catalogue NumberPTA3-14-90-3-4
Device Lot Number8765543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2018
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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