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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 G34339
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problems Thrombus (2101); Foreign Body In Patient (2687); No Code Available (3191)
Event Date 02/26/2020
Event Type  Injury  
Manufacturer Narrative
Initial reporter occupation
=
office manager. (b)(4). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during a revascularization procedure of the superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured circumferentially at 22 atmospheres. A cook sphere inflation device was used to inflate the balloon one time with a 50/50 ratio of omnipaque contrast. The 70% stenosed lesion was at the origin of a previous superficial femoral-popliteal bypass anastomosis. No calcification or tortuosity was reported. The balloon was unable to be removed by itself; therefore, the balloon was removed together with a 5 french 45 centimeter ansel sheath and unknown wire guide. After removal, the user realized that the distal one-third of the balloon had separated, and part of the balloon was left in the patient. Blood was noted in the inflation device as the device was withdrawn. The balloon was not inflated within a stent prior to rupture. The patient reportedly presented to the emergency room the following day with a thrombus "cold leg". Emergency surgery was performed. Additional information has been requested, but is unavailable at this time.
 
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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 Key9834960
MDR Text Key196399282
Report Number1820334-2020-00614
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130293
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 09/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/07/2021
Device Model NumberG34339
Device Catalogue NumberPTA4-18-150-7-4
Device Lot Number9294400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2020 Patient Sequence Number: 1
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