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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 G30964
Device Problem Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Occupation: radiology tech. Device evaluated by mfg: device evaluation has begun; however, a conclusion is not yet available. 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 left popliteal angioplasty, an advance 18 lp low profile balloon catheter leaked from a pinhole in the balloon. The balloon was advanced through a 6 french ansel sheath to treat the mildly calcified left popliteal and superficial femoral arteries. No vessel angulation or tortuosity was reported. The balloon was inflated once using a cook sphere inflation device and 90/10 omnipaque contrast. Reportedly, the device began losing pressure once it reached 8 atmospheres. The balloon was thus removed through the sheath, and a pin-hole leak was confirmed to the proximal end of the balloon using a saline bench test. Blood was noted in the inflation device prior to balloon removal. The balloon was not inflated within a stent. Another balloon of a different size was opened and used to complete the procedure successfully. 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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9854007
MDR Text Key184137377
Report Number1820334-2020-00648
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG30964
Device Catalogue NumberPTA4-18-150-6-20
Device Lot Number10181038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2019
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: 03/19/2020 Patient Sequence Number: 1
Treatment
6 FRENCH ANSEL SHEATH, SPHERE INFLATION DEVICE
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