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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 G30897
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem No Code Available (3191)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant products
=
philips pioneer catheter, 014 roadrunner, merit 5/6fr sheath. Reporter occupation
=
lab 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 an interventional procedure for a chronic total occlusion of the left superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured and separated. The lesion was crossed using another manufacturer's catheter and the lesion was pre-dilated with a cook 2x6 18lp balloon. The complaint device was then inserted over a cook 0. 014 inch roadrunner wire guide. The balloon was inflated to approximately five or six atmospheres using a 50/50 ratio of omnipaque contrast to saline, at which point the balloon ruptured. The user then attempted to remove the balloon over the wire; however, it became stuck, possibly within the heavily calcified lesion, and separated. The sheath and balloon catheter were removed as a unit. The distal marker and separated portion of the balloon were left in the body, wrapped around the wire guide. A 6x13 cook performer sheath was then inserted and the user removed the separated portion of the device by pulling the wire guide and balloon fragment through the sheath. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10706673
MDR Text Key212160857
Report Number1820334-2020-01907
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 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/09/2021
Device Model NumberG30897
Device Catalogue NumberPTA4-18-80-4-20
Device Lot Number9222176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2018
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: 10/20/2020 Patient Sequence Number: 1
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