MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The balloon ruptured circumferentially and the distal end was unable to be removed.The patient went to the operating room for an endarterectomy and removal of the fractured balloon.

Manufacturer Narrative

Correction: the date of incident was reported as (b)(6) 2015.Investigation - evaluation.A review of complaint history, device record history, documentation, instructions for use (ifu), quality control and visual inspection of the returned device was conducted during the investigation.The visual examination reported the wire guide that was returned with the device is lodged in the catheter shaft, and extends past the remaining proximal piece of balloon.The wire guide measures 0.033" and 81 cm of balloon shaft returned with 1.4 cm segment of balloon still attached past the neck proximal bond.Catheter under the balloon is severely stretched, evidenced by accordioned and lighter colored extrusion, 2cm segment of remaining distal end of catheter exhibits this damage.Although the user did not report the pressure used during the procedure, if the user did inflate the device over the rbp of 8 atm, then over-inflation could have contributed to the balloon rupture.Neither did the user report calcification or angulation, but calcification and angulation can contribute to ruptures.It is also possible that if the device was attempted to be withdrawn through a sheath or introducer following rupture, the sheath or introducer could have caused difficult removal (as balloon rewrap would be difficult) and aided in the separation, but this cannot be confirmed.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.There is no evidence to suggest that the device was not manufactured per specifications.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in fig.1.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures." "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." the appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

The balloon was used in a leg angioplasty procedure and the balloon ruptured while in the patient.Upon removal of the balloon, there was a circumferential rupture and the distal end remained in the patient.The patient went to the operating room for an endarterectomy, removal of the fractured balloon and fragment.

• Brand Name: ATB ADVANCE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5313270
• MDR Text Key: 33952207
• Report Number: 1820334-2015-00863
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K063252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ATB5-35-80-14-4.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2015
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2015
• 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