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

Model Number N/A

Device Problems Balloon rupture (1049); Material Rupture (1546)

Patient Problems Rupture (2208); Foreign body, removal of (2365)

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.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT 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 Key: 4795524
• MDR Text Key: 5817764
• Report Number: 1820334-2015-00309
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2018
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-135-5-20.0
• Device Lot Number: 5672052
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2015
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR