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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 LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G50340
Device Problem Flaked (1246)
Patient Problem No Patient Involvement (2645)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
Profession: non healthcare professional. Pma/510(k) number: k170193. 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, after opening the package, material was seen "coming off" the advance 14 lp low profile balloon catheter. The device never made patient contact. Reportedly, it was stored a sixty-eight degrees.
 
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Brand NameADVANCE 14 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key8478926
MDR Text Key140945139
Report Number1820334-2019-00745
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
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 05/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/20/2020
Device Model NumberG50340
Device Catalogue NumberPTAX4-14-170-4-20
Device Lot Number8310214
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2017
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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