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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Balloon rupture; Material Rupture
Event Date 04/24/2015
Event Type  Injury  
Event Description

During percutaneous transluminal angioplasty stenting of the superficial femoral artery (sfa) in the (b)(6) female patient, the facility first used another manufacturer's balloon. Difficult advancement was experienced. The device was removed. The user elected to open and use a balloon catheter, which was placed in the sfa. The balloon was inflated to 15 atm's when it burst, rupturing the patient's artery. There was an attempt to remove the balloon by pulling it back out over the wire; however, the proximal two thirds of the balloon came out and the distal third remained within the patient. The physician did a cut down on the patient and removed the remaining piece of balloon. Ultimately another balloon was opened and used to complete the procedure with no further issues. The patient went home the next day as planned. Per the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Event is still under investigation.

 
Manufacturer Narrative

(b)(4). Event evaluation: a review of complaint history, documentation, instructions for use (ifu), quality control, specifications, and trends was conducted during the investigation. The device was not returned for investigation. Per the dfmea (design failure mode and effect analysis), balloon burst, compliance, and fatigue verification testing have been performed. The rated burst pressure (rbp) is documented in the compliance card and label. There is no evidence to suggest that the device was not manufactured per specifications. Each device is shipped with ifu which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures. The ifu states: do not exceed rated burst pressure. Rupture of balloon may occur. Adhere to balloon inflation pressure parameters in the compliance card insert. Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall. Do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur. The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit. The user reported that the balloon was inflated to 15 atm when it burst. The rated burst pressure of the balloon is 15 atm, thus if the user did exceed the 15 atm, over-inflation could be the cause of the rupture but this was not reported. The user reported a circumferential burst. The user reported that a 6 fr sheath/introducer was used, but did not report if this was removed with the balloon during withdrawal or if withdrawal was attempted through the 6 fr sheath. The balloons are designed to burst linearly, but a circumferentially burst or tear may occur in certain instances such as an unexpected sharp calcification. Calcification was noted in the patient, but it is unknown whether the calcification or a sharp protrusion in the calcification played a role in the balloon burst. A circumferential burst would make balloon rewrap more difficult, especially if withdrawal was attempted through an introducer or sheath, and may increase the chances of separation. A definitive root cause cannot be determined. We have notified the appropriate internal personnel and will continue to monitor for similar complaints.

 
Event Description

During percutaneous transluminal angioplasty stenting of the superficial femoral artery (sfa) in the (b)(6) female patient, the facility first used another manufacturer's balloon. Difficult advancement was experienced. The device was removed. The user elected to open and use a balloon catheter; which was placed in the sfa. The balloon was inflated to 15 atm's when it burst, rupturing the patient's artery. There was an attempt to remove the balloon by pulling it back out over the wire; however, the proximal two thirds of the balloon came out and the distal third remained within the patient. The physician did a cut down on the patient and removed the remaining piece of balloon. Ultimately another balloon was opened and used to complete the procedure with no further issues. The patient went home the next day as planned. Per the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington , IN 47404
8128294891
MDR Report Key4795524
Report Number1820334-2015-00309
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/24/2018
Device MODEL NumberN/A
Device Catalogue NumberPTA5-35-135-5-20.0
Device LOT Number5672052
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/24/2015
Device Age2 mo
Event Location Hospital
Date Manufacturer Received04/29/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/24/2015
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: 05/21/2015 Patient Sequence Number: 1
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