MAUDE Adverse Event Report: MEDTRONIC INC. CELLO BALLOON GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number 1610060

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Cello 6 french balloon guide catheter repeatedly deflated during procedure; however, able to measure stump pressure so passed balloon test occlusion.Representative was notified and device was given to them.

• Brand Name: CELLO BALLOON GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 13341704
• MDR Text Key: 284360520
• Report Number: 13341704
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 1610060
• Device Catalogue Number: 1610060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White