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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G34319
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k) number
=
k130293. 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, a patient of unknown age and gender underwent a below the knee leg procedure utilizing an advance 18 low profile balloon catheter. The patient's anatomy was not angled, calcified or tortuous. During the initial inflation of the balloon, contrast started leaking out. The balloon was removed through the sheath and another of the same was used to complete the procedure. A cook six french sheath and a cook inflation device were also used during the procedure along with isovue contrast in a 50/50 ratio with saline. The patient did not experience any adverse effects, no additional procedures were required and nothing had to be retrieved from the patient.
 
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Brand NameADVANCE 18 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 Key8457348
MDR Text Key140165655
Report Number1820334-2019-00697
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2021
Device Model NumberG34319
Device Catalogue NumberPTA4-18-150-3-4
Device Lot Number8589648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2018
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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