• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G50317
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2019
Event Type  malfunction  
Manufacturer Narrative
Occupation
=
unknown. Pma/510(k) number
=
k170193. 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, during a right lower limb peripheral angioplasty, the advance 14 lp low profile balloon catheter experienced a leakage. During the procedure a liquid contrast of 3ml by 7ml saline was used. The balloon was properly inserted through a 6fr cook sheath with the tip being guided to the lesion in the anterior tibial artery without any difficulty. Two attempts were made to inflate the balloon using an unknown inflation device for "about" two minutes; however, the balloon did not inflate and instead of holding, the pressure gauge was falling slowly. Upon removing the device from the patient, a leak from the proximal end of the balloon was noted. Reportedly, the lesion did not contain any angulation, tortuosity, or calcification; however, it was noted to have been "about 60%" occluded, with several points of occlusion in the segment being treated. Despite the incident, the distal recanalization procedure was successfully completed. A section of the device did not remain inside the patient¿s body. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9130828
MDR Text Key176457950
Report Number1820334-2019-02440
Device Sequence Number1
Product Code LIT
UDI-Device Identifier10827002503172
UDI-Public(01)10827002503172(17)210623(10)NS8973682
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2021
Device Model NumberG50317
Device Catalogue NumberPTAX4-14-170-2-12
Device Lot NumberNS8973682
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-