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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 G35532
Device Problem Fluid Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation: (b)(6). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
As reported, during an angioplasty using an advance 35 lp low profile balloon catheter, the balloon leaked. The physician advanced the balloon catheter into position with no difficulties. Upon the initial inflation, the balloon leaked into the vessel and failed to hold pressure. There was no angulation, vessel tortuosity, or vessel calcification noted. The device was removed and another same type device was used to complete the procedure with no further complications. No device segment remained inside of the patient. No additional procedures were needed as a result of this occurrence. No adverse effects were reported as a result of this occurrence.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10870296
MDR Text Key223770460
Report Number1820334-2020-02164
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG35532
Device Catalogue NumberPTA5-35-135-5-20.0
Device Lot Number10332055
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2020
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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