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

Catalog Number	AUBS-4-6
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/11/2017
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
As reported by the distributor, the ascend® aq® ureteral balloon catheter was injected with about 2-3 ml of saline solution then the balloon ruptured longitudinally.This observation was made prior to patient contact.No other information has been provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of complaint history, the device history record, drawings, manufacturing instructions, quality control and specifications was performed.A visual inspection and functional testing was also conducted.Two balloon catheters and two inflation devices were returned for evaluation.A functional test was performed on both catheters.One catheter was found to have a split in the balloon material and the other catheter had a split and the balloon material had a scraped appearance.This complaint is confirmed.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 this product and lot number 7783515.Based on the provided information, this complaint is confirmed, however 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: 6908396
• Report Number: 1820334-2017-03415
• Device Sequence Number: 116433
• Product Code: EZN
• UDI-Device Identifier: 00827002328358
• UDI-Public: (01)00827002328358(17)200328(10)7783515
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: AUBS-4-6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1