• 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 G34323
Device Problems Fluid Leak; Material Puncture/Hole
Event Date 09/26/2019
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter occupation: lead tech. Pma/510(k) number: k130293. 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 percutaneous transluminal angioplasty of the distal end of a venous bypass of the superficial femoral artery, involving a female patient in her "60s or 70's, the advance 18 lp low profile balloon catheter experienced a leak. Access was gained using a 5 fr cook sheath, and following the first inflation attempt using an unknown inflation device, a pinhole was noted after reaching 1 atm of pressure. Upon observing contrast "blooming" into the vessel, the physician deflated and removed the balloon, by itself, from the patient. Reportedly, the contrast used was a 50/50 contrast/saline ratio. The patient did not have much tortuosity or calcification, and "no unreasonable amount of angulation". However, the lesion was noted to contain 75% stenosis. According to the initial reporter, a competitor's device was used to complete the procedure. 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
jennifer canada
750 daniels way
bloomington , IN 47404
8123392235
MDR Report Key9134204
Report Number1820334-2019-02446
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/23/2020
Device MODEL NumberG34323
Device Catalogue NumberPTA4-18-150-4-2
Device LOT Number7772248
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/03/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-