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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G50326
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2022
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
As reported, during an angioplasty procedure and using a advance 14 lp low profile balloon catheter, the balloon quickly lost pressure due to a pinhole in the balloon material. An inflation device was used. And the inflation pressure did not make it past 6atm. Inflation failed during the first attempt. A 5fr cook sheath of unknown length was also utilized during the procedure. Patient's anatomy was not noted to be tortuous or calcified. The lesion was located in the posterior tibial artery. The balloon was removed through the sheath. The procedure was successfully completed with another device of the same type. No unintended section of the device remained inside of the patient's body. No additional procedures were required due to the occurrence. No adverse effects were reported due to the occurrence.
 
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
As reported, during an angioplasty procedure and using a advance 14 lp low profile balloon catheter, the balloon quickly lost pressure due to a pinhole in the balloon material. An inflation device was used. And the inflation pressure did not make it past 6atm. Inflation failed during the first attempt. A 5fr cook sheath of unknown length was also utilized during the procedure. Patient's anatomy was not noted to be tortuous or calcified. The lesion was located in the posterior tibial artery. The balloon was removed through the sheath. The procedure was successfully completed with another device of the same type. No unintended section of the device remained inside of the patient's body. No additional procedures were required due to the occurrence. No adverse effects were reported due to the occurrence.
 
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Brand NameADVANCE 14 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 Key13524589
MDR Text Key286147046
Report Number1820334-2022-00224
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170193
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 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG50326
Device Catalogue NumberPTAX4-14-170-2.5-20
Device Lot Number13532873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/14/2022 Patient Sequence Number: 1
Treatment
5FR COOK SHEATH
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