• 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 18 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 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G34319
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
Occupation: non-healthcare professional. Pma/510(k) number
=
k130293. This report includes information known at this time. A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
 
Event Description
It was reported, a patient (demographics unknown) was undergoing an unspecified procedure using an advance 18 lp low profile balloon catheter. Target treatment area was a left below the knee location. The balloon was inserted to the desired vessel, markers were visualized, and an unsuccessful attempt was made to inflate the complaint balloon. It was inflated to nominal pressure. Omeron contrast in a 50/50 mix with saline could be seen filling the proximal vessels. At this point the balloon was deflated and removed without the sheath. It was not ruptured but suspected of leaking at the proximal connection to the shaft. A new balloon was used to successfully complete the procedure. According to the complainant, a 6fr sheath(cook) and an unspecified inflation device were used with the complaint device. No blood was noted in the inflation device. Additionally, the patient's anatomy was severely calcified without tortuosity or angulation. The balloon was not inflated inside a stent. 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 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
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8633573
MDR Text Key146370230
Report Number1820334-2019-01276
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/22/2021
Device Model NumberG34319
Device Catalogue NumberPTA4-18-150-3-4
Device Lot Number9111088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-