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

Catalog Number	AUB-5-6
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported the ascend® aq® ureteral balloon catheter was prepared to be used in an endoscopic lithotripsy ureteral dilation for expansion of ureteral stenosis.The user filled the balloon with water and a small amount of resistance was met.Then the balloon was found to have broken longitudinally.This occurred prior to patient contact and a new device was used to complete the procedure.There was no patient contact and no impact to the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: one ascend® aq® ureteral balloon catheter was returned for evaluation.A visual examination noted the balloon material has a cut vertically and is then split horizontally.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and no non-conformances were noted.A review of complaint history for this product/lot number combination revealed there are no other complaints associated with lot number ns6383022.The instructions for use (ifu) contains the warning: do not over inflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.Based on the provided information a definitive root cause cannot be established at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6821712
• Report Number: 1820334-2017-02773
• Device Sequence Number: 1601166
• Product Code: EZN
• UDI-Device Identifier: 00827002328297
• UDI-Public: (01)00827002328297(17)181115(10)NS6383022
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AUB-5-6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1