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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Extravasation (1842); No Code Available (3191)
Date of Event	08/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.(b)(4).
Event or Problem Description
Voluntary event report mw5064094 was received 24aug2016.Information was provided that the physician was doing a cystourethroscopy procedure on a patient using a flexible ureteroscope.Difficulty was experienced advancing the scope so the physician elected to use a ureteral balloon dilation.The physician began filling the balloon with contrast material and at 10 atm of pressure, he suddenly lost pressure.Vulvoscopy confirmed the balloon had burst and there was extravasation of contrast in the area.The balloon was removed with little difficulty.Upon removal, the doctor examined the balloon and found no evidence of pieces missing and the balloon was still intact.However, there was a clear perforation of the balloon.At this point the procedure was aborted and due to the extravasation of contrast, the doctor elected to place a ureteral stent.Although the patient did not have an additional procedure, a longer term stent (10 days vs 3 days) was required.Additional information regarding patient outcome stated there was rupture of the ureter as evidenced by dye extravasation.No additional information has been provided.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported was bio matter is visible on the balloon; the device was returned with a 4 cm longitudinal split in the balloon material and a functional test was performed on the unopened device and it functioned as intended.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
Voluntary event report mw5064094 was received 24aug2016.Information was provided that the physician was doing a cystourethroscopy procedure on a patient using a flexible ureteroscope.Difficulty was experienced advancing the scope so the physician elected to use a ureteral balloon dilation.The physician began filling the balloon with contrast material and at 10 atm of pressure, he suddenly lost pressure.Vulvoscopy confirmed the balloon had burst and there was extravasation of contrast in the area.The balloon was removed with little difficulty.Upon removal, the doctor examined the balloon and found no evidence of pieces missing and the balloon was still intact.However, there was a clear perforation of the balloon.At this point the procedure was aborted and due to the extravasation of contrast, the doctor elected to place a ureteral stent.Although the patient did not have an additional procedure, a longer term stent (10 days vs 3 days) was required.Additional information regarding patient outcome stated there was rupture of the ureter as evidenced by dye extravasation.No additional information has been provided.

• Brand Name: ASCEND® AQ® URETERAL BALLOON CATHETER
• Common Device Name: EZN DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5938696
• Report Number: 1820334-2016-00920
• Device Sequence Number: 671023
• Product Code: EZN
• UDI-Device Identifier: 00827002328372
• UDI-Public: (01)00827002328372(17)190412(10)6884139
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K040127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AUBS-5-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2016
• Supplement Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention