• 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 G34359
Device Problem Material Puncture / Hole
Event Date 04/17/2019
Event Type  Malfunction  
Manufacturer Narrative

Occupation: unknown. Pma/510(k) number = 17184. 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 (b)(6) female was undergoing angioplasty of the superficial femoral (sfa) and posterior tibial arteries. An advance 35 lp low profile balloon catheter was introduced over the 0. 35 wire and positioned where required in the sfa. The balloon would not inflate during the procedure, never reaching 5 atmospheres (atm). Contrast was noted to be running out of the balloon at approximately 4 atm. A 50/50 mix of contrast to saline was used during the attempted inflation. The complaint balloon was removed over a cook wire and through a 5 fr cook sheath and a tiny hole was noted at one end. Blood was observed in the inflation device. The balloon was not inflated inside a stent. The patient's anatomy was noted to have "very slight tortuosity in the sfa" and stenosis, however calcification was not noted. 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 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 Key8570723
Report Number1820334-2019-00942
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG34359
Device Catalogue NumberPTA5-35-80-5-20.0
Device LOT Number8758979
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/23/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/09/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-