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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

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COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G35536
Device Problems Leak / Splash; Material Puncture / Hole
Event Date 05/17/2019
Event Type  Malfunction  
Manufacturer Narrative

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) year old male patient with a history of coronary artery disease, diabetes (type unspecified) and hypertension, underwent an unknown procedure in which the advance 35 lp low profile balloon catheter was used. It was noted that the patient had plaque and calcium build up in the superficial femoral artery (sfa). The lesion was located in the distal sfa. ,which was seventy per cent occluded. There were no issues gaining access in the groin. At approximately mid to distal sfa, the initial inflation of the balloon inside a stent was taken up to 15 atmospheres (atm). The balloon started to leak and blood backed up into the inflation device due to a hole in the balloon. The physician removed the device intact without a sheath and used another balloon to complete the procedure. Nothing detached in the patient. No tortuosity or angulation was present in the patient's vessel. Optiray contrast in a 50/50 ratio to saline was used to inflate the balloon. No additional procedures were required. The patient did not experience any adverse effect.

 
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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 Key8639936
Report Number1820334-2019-01257
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG35536
Device Catalogue NumberPTA5-35-135-6-20.0
Device LOT Number9490830
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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