• 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 G50325
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
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 an unspecified procedure, an advance 14 lp low profile balloon catheter leaked contrast. The device was advanced to the anterior tibial artery and the user attempted to inflate the balloon, which would not inflate over seven atmospheres. A leak was noted "near" the balloon. The device was replaced with a new balloon and the procedure was completed successfully. 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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12303203
MDR Text Key266022664
Report Number1820334-2021-01952
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 Other,Foreign,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG50325
Device Catalogue NumberPTAX4-14-170-2.5-16
Device Lot Number13348635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-