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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 G30903
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/03/2022
Event Type  Injury  
Event Description
As reported, during percutaneous transluminal angioplasty of the lower limb, an advance 18 lp low profile balloon catheter ruptured and separated. Per the user, after the balloon ruptured, half of the balloon and balloon catheter separated upon removal of the device. Reportedly, the user felt "something like a structural weakness". An open endarterectomy using sedoanalgesia was performed to retrieve the balloon and balloon catheter from the superficial femoral artery. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Customer name and address: (b)(6). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
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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 Key14083545
MDR Text Key289062119
Report Number1820334-2022-00558
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,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30903
Device Catalogue NumberPTA4-18-80-5-20
Device Lot Number14368903
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2021
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: 04/12/2022 Patient Sequence Number: 1
Treatment
5 FR CORDIS BRITE TIP SHEATH
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