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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
Catalog Number PTA4-18-150-2-20
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 03/21/2018
Event Type  Injury  
Manufacturer Narrative
Per the initial reporter, the device will not be returned. (b)(4). 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 that during a balloon angioplasty of the very highly calcified anterior tibial artery, the advance 18 lp low profile balloon catheter burst leaving a piece of the device in the patients vessel. The patient reportedly had a foot wound and was undergoing an angioplasty as the last attempt to improve blood flow. There were several unspecified problems regarding the arteries of this limb. As the balloon was dilated to 6 "bars" it burst as contacted the sharp calcifications of the arteria tibialis anterior (ata). The tip of the balloon got stuck, and as the balloon catheter was being removed, it broke and the tip was left in the distal end of the ata. The physician tried to push the broken part of the advance 18 lp low profile balloon catheter to a larger part of the vessel with another manufacturer's support catheter without success. This second support catheter reportedly also broke and a piece was left in the patient's vessel. Additional information regarding event details, patient anatomy and outcome has been requested, but is not available 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 Key7446630
MDR Text Key106034573
Report Number1820334-2018-00981
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPTA4-18-150-2-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/20/2018 Patient Sequence Number: 1
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