MAUDE Adverse Event Report: COOK INCORPORATED ADVANCE; CATHETER, PERCUTANEOUS

Model Number G52272

Device Problems Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2019

Event Type  malfunction  

Event Description

Balloon popped and was dislodged in the patient's left arm.The balloon was able to be removed using a snare device.

• Brand Name: ADVANCE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8657811
• MDR Text Key: 146634281
• Report Number: 8657811
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G52272
• Device Catalogue Number: PTA5-35-135-7-4.0
• Device Lot Number: 9257630
• 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: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32485 DA