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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G50319
Device Problem Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Manufacturer Narrative
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, 4. 5fr sheath was inserted into the thrombotic occlusive lesion existing from the right popliteal artery to the posterior tibial artery. A right femoral artery approach was used. There was no angulation or vessel calcification noted. After passing through a 0. 014inch wire guide, the physician dilated the lesion with the reported advance 14 lp low profile balloon catheter (2mm × 20mm). For sizing-up of the balloon catheter, the physician tried to pull the reported balloon out of the sheath, but the balloon catheter was unable to be pulled out of the sheath. Therefore, the sheath and the reported balloon catheter were removed together. After that, a new 4. 5 fr sheath was inserted into the patient, and the physician used 2 advance14lp which were bigger sizes than the reported balloon catheter and dilated the lesion. The 2 advance14lp were removed from the patient's body without any problems. The procedure was completed without any problems. No adverse effects were reported due to this occurrence.
 
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Brand NameADVANCE 14 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 Key11273140
MDR Text Key255111604
Report Number1820334-2021-00243
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K170193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG50319
Device Catalogue NumberPTAX4-14-170-2-20
Device Lot Number13303004
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 Received04/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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