MAUDE Adverse Event Report: COOK INCORPORATED ASCEND AQ; DILATOR, CATHETER, URETERAL

Model Number G32835

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Balloon lost its integrity.A new balloon had to be opened to complete the procedure.Product had patient contact but no patient harm.Product is available to be returned to the manufacturer.

• Brand Name: ASCEND AQ
• Type of Device: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7836640
• MDR Text Key: 118881299
• Report Number: 7836640
• Device Sequence Number: 1
• Product Code: EZN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G32835
• Device Catalogue Number: AUBS-4-6
• Device Lot Number: 7570408
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1