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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 G34359
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
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 a right superficial femoral artery balloon angioplasty procedure, the advance 35 lp low profile balloon catheter leaked. While inflating the device under x-ray guidance, contrast was noted to be leaking from the proximal section of the balloon. At that time, the balloon was withdrawn and removed from the procedure. There was no harm to the patient. 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. Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
 
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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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9152806
MDR Text Key176600186
Report Number1820334-2019-02529
Device Sequence Number1
Product Code LIT
UDI-Device Identifier10827002343594
UDI-Public(01)10827002343594(17)220716(10)9881875
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K132020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/16/2022
Device Model NumberG34359
Device Catalogue NumberPTA5-35-80-5-20.0
Device Lot Number9881875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2019
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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