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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 PTA5-35-135-3-6.0
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2019
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 the advance 35 lp low profile balloon catheter leaked during an unspecified angioplasty procedure involving a (b)(6) year-old female patient with a history of "arterial peripheral disease. " the balloon was properly introduced, with the distal tip reaching the injury site without complication. Reportedly, the lesion being treated was a non-occlusive stenosis with moderate calcification. As the physician began inflating the complaint device, the pressure on of the insufflator would not "hold", and slowly decreased. When the physician withdrew the device from the patient, the balloon was leaking form the proximal end, near the connection point between the balloon material and the shaft. 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.
 
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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 Key8796727
MDR Text Key151764793
Report Number1820334-2019-01710
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/22/2021
Device Model NumberPTA5-35-135-3-6.0
Device Catalogue NumberPTA5-35-135-3-6.0
Device Lot Number8525861
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 Received08/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2018
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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