• 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 G50326
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2022
Event Type  malfunction  
Event Description
As reported, an advance 14 lp low profile balloon catheter could not be inflated due to leakage from the balloon. The device was inserted through another manufacturer's sheath to access the 70% occluded anterior tibial artery lesion. The vessel was slightly calcified but neither tortuous nor angulated. The device was inflated once to 15 atmospheres for 30 seconds before leakage of contrast was discovered. The device was removed from the patient, and a new device was used to continue the procedure. When testing the device outside of the patient, the balloon was found damaged and still could not be inflated. 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.
 
Manufacturer Narrative
This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
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 Key14013314
MDR Text Key291327171
Report Number1820334-2022-00530
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 07/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG50326
Device Catalogue NumberPTAX4-14-170-2.5-20
Device Lot Number14026709
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2021
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: 04/05/2022 Patient Sequence Number: 1
Treatment
TERUMO 6FR SHEATH
-
-