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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 G30970
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation: manager. 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, an advance 18 lp low profile balloon catheter ruptured. The target location was the left superficial femoral artery. An inflation device was used to inflate the balloon twice before rupturing on the second inflation to nominal pressure. The device was removed from the patient, and the procedure was completed with a new balloon. There was no delay in treatment. It was initially reported that no stent was used during the procedure, but information was later received that the balloon was inflated inside of a stent prior to the rupture. Clarification has been requested. A section of the device did not remain inside the patient. The patient did not require any additional procedures due to the occurrence. According to the initial reporter, the patient did not experience any adverse effects.
 
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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 Key14254858
MDR Text Key290528761
Report Number1820334-2022-00672
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
Report Date 04/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30970
Device Catalogue NumberPTA4-18-150-7-20
Device Lot Number13728755
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
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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