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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS

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COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTAX4-14-170-4-20
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 10/10/2018
Event Type  malfunction  
Manufacturer Narrative
Non-healthcare professional 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, during preparation for an aortic runoff procedure, the advance 14 lp low profile balloon catheter material was noted to be frayed and crimped upon removal from the packaging. It was not nicely wrapped. The device did not make patient contact. The procedure was successfully completed with another device of the same type. No patient adverse effect has been reported.
 
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Brand NameADVANCE 14 LP LOW PROFILE 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 Key7993715
MDR Text Key124685344
Report Number1820334-2018-03182
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090822
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 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/23/2021
Device Catalogue NumberPTAX4-14-170-4-20
Device Lot Number8903931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2018
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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