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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
Model Number G30937
Device Problem Material Puncture/Hole (1504)
Patient Problem Insufficient Information (4580)
Event Date 03/11/2022
Event Type  malfunction  
Manufacturer Narrative
Occupation: purchasing. Device has been received by the manufacturer but investigation has not began yet. 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 unspecified procedure using a advance 18 lp low profile balloon catheter, there was a hole noted in the balloon material of the device. Additional patient and event information has been requested.
 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13952830
MDR Text Key291963112
Report Number1820334-2022-00490
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130293
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30937
Device Catalogue NumberPTA4-18-150-2-12
Device Lot Number14294677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received05/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2021
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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