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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 G30901
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/24/2022
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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 percutaneous transluminal angioplasty of the popliteal artery, an advance 18 lp low profile balloon catheter ruptured and separated. After the balloon ruptured, it was unable to be removed from an unknown introducer and subsequently separated, leaving half of the balloon over an unknown wire in the superficial femoral artery (sfa). A bare metal stent was placed in the sfa to hold the fragment in place and prevent migration. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information has been requested.
 
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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 Key14164086
MDR Text Key289739060
Report Number1820334-2022-00615
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K130293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30901
Device Catalogue NumberPTA4-18-80-5-15
Device Lot Number13934644
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2021
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: 04/20/2022 Patient Sequence Number: 1
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