• 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 35 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 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G34373
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter occupation
=
non-healthcare professional. (b)(4). 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 that during a left femoral tripod endarterectomy and iliac angioplasty for intra-stent restenosis procedure, an advance 35 lp low profile balloon catheter ruptured. The balloon was inflated to nominal pressure at the time of rupture. The patient was reported to have lost approximately 70-100 milliliters of blood as a result of the event. An arteriotomy was performed to retrieve the balloon, prolonging the procedure by approximately 30 minutes. The procedure was completed without any consequence to the patient. There has been no report that any part of the device remained in the patient's body. The patient did not experience any adverse effects due to this occurrence. Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADVANCE 35 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 Key8326576
MDR Text Key135742442
Report Number1820334-2019-00273
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/26/2021
Device Model NumberG34373
Device Catalogue NumberPTA5-35-80-10-2.0
Device Lot Number9331396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2018
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: 02/11/2019 Patient Sequence Number: 1
-
-