MAUDE Adverse Event Report: COOK, INC. ASCEND® AQ® URETERAL BALLOON CATHETER; EZN DILATOR, CATHETER, URETERAL

Model Number N/A

Device Problems Balloon rupture (1049); Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/29/2015

Event Type  Injury  

Event Description

During a ureteral stone extraction procedure with a holium laser, the ascend balloon catheter was used during a left ureteral dilation.The procedure was complete, when a piece of plastic came out of the left ureter was noticed.The physician re-inflated the balloon that had been removed from the patient and it leaked.It was noted that the fragmented piece was plastic from the balloon.According to the initial reporter, there was no harm to the patient.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Investigation / evaluation: during the course of investigation, an interview with manufacturing/production personnel, along with a review of the complaint history, documentation, and a visual examination of the returned opened, used and damaged device was conducted.The examination of the returned device included a piece of the balloon; which had separated off from the device.The separated piece measured approximately 4.8 cm in length and roughly 1-3 mm wide at different points.The missing segment was visible on the balloon catheter, and showed that the fragmented piece separated outside of the balloon bond areas (bonds were not compromised).The distal end of the tear on both the fragmented piece and balloon both had a "lip" that flared outward.The angle of the lip/flare indicates that it is likely that the tear began more towards the proximal end, and separated at the distal end (possible during manipulation or withdrawal of the device).The fragmented portion was not representative of a balloon rupture, thus it is believed that the balloon did not rupture.The balloon was inspected under a microscope to look for signs of damage elsewhere on the balloon or near the tear.However, due to the dried contrast within the balloon (which is clear in color as is the balloon) it was difficult to see any possible damages.The device is 100% inspected per quality control specification.Qc personnel assure bonds have a smooth transition to catheter, leak test the device, confirm outside diameter of balloon and assure balloon bonds are free of voids and that the balloon deflates properly.The device is supplied with an instructions for use, which lists appropriate uses, warnings and precautions, potential adverse events, and proper usage instructions.Although it is possible that the balloon could have been damaged by a stone, tough stricture, or by other instrumentation used during the procedure; a definitive root cause cannot be determined.As the description of event stated that the procedure was complete when a plastic piece fell out of the left ureter, it is assumed that the piece was in the bladder.It is likely that the piece was removed via minimally invasive methods.We have notified appropriate personnel and will continue to monitor for similar complaints.No additional risk mitigating activities are required at this time.

Event Description

During a ureteral stone extraction procedure with a holium laser, the ascend balloon catheter was used during a left ureteral dilation.The procedure was complete when it was noted that a piece of plastic came out of the left ureter of the patient.The physician re-inflated the balloon that had been removed from the patient and leakage was found.It was noted that the fragmented piece was plastic from the balloon.According to the initial reporter, there was no harm to the patient.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ASCEND® AQ® URETERAL BALLOON CATHETER
• Type of Device: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4947118
• MDR Text Key: 6033710
• Report Number: 1820334-2015-00433
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2018
• Device Model Number: N/A
• Device Catalogue Number: AUBS-5-4
• Device Lot Number: 5693006
• Other Device ID Number: UDI#: (01)00827002328372(17)18
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2015
• 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): Other