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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PTA4-18-150-3-20
Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma
=
k130293. 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 fistulagram procedure, the balloon of the advance 18 lp low profile balloon catheter was found to have a hole in it. This was discovered when the balloon was inflated and contrast was injected. The contrast leaked out of the balloon. The complainant denied any scarring, calcification, or tortuosity of the patient's anatomy. The advance 18 lp low profile balloon catheter was removed and the procedure was successfully completed using another. 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 18 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 Key7587878
MDR Text Key110720616
Report Number1820334-2018-01608
Device Sequence Number1
Product Code LIT
UDI-Device Identifier10827002309460
UDI-Public(01)10827002309460(17)210427(10)8846664
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPTA4-18-150-3-20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2018
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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