MAUDE Adverse Event Report: COOK ENDOSCOPY ASCEND AQ URETERAL DILATION BALLOON CATHETER SET

Model Number AUBS-5-4

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Extravasation (1842)

Event Date 08/10/2016

Event Type  Injury  

Event Description

Doctor was doing a cystourethroscopy on pt using flexible ureteroscope.He had difficulty advancing scope so he elected to do ureteral balloon dilation using a cook ureteral balloon ref # aub-5-4 (g32837 lot #6884139) balloon was placed on sterile field and doctor was informed of the allowed atm of 14 with burst pressure of 20 atm by circulator.Doctor started 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 a little difficulty.The doctor examined the balloon upon removal and found no evidence of pieces missing and the balloon saw still intact.However, there was a clear perforation of the balloon.At this point due to the extravasation of contrast the doctor elected to place a ureteral stent.Cook incorporated, (b)(4).Dates of use: (b)(6) 2016.Diagnosis or reason for use: dilation of ureter.

• Brand Name: ASCEND AQ URETERAL DILATION BALLOON CATHETER SET
• Type of Device: ASCEND AQ URETERAL DILATION BALLOON CATHETER SET
• Manufacturer (Section D): COOK ENDOSCOPY; winston salem NC
• MDR Report Key: 5878286
• MDR Text Key: 52349915
• Report Number: MW5064094
• Device Sequence Number: 1
• Product Code: EZN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2019
• Device Model Number: AUBS-5-4
• Device Catalogue Number: G32837
• Device Lot Number: 6884139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 78