MAUDE Adverse Event Report: CHELSEA SPECIALTIES, LLC CELLO¿, BALLOON GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	9F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When prepping the balloon of the catheter it flushed out the side where the wire typically runs through instead of the balloon lumen.

• Brand Name: CELLO¿, BALLOON GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CHELSEA SPECIALTIES, LLC; 13829 riker road; chelsea MI 48118
• MDR Report Key: 7663199
• Report Number: 7663199
• Device Sequence Number: 2501654
• Product Code: DQY
• UDI-Device Identifier: 04544050093491
• UDI-Public: (01)04544050093491
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/22/2018
• Report Date (Section F): 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9F
• Device Catalogue Number: 1510590
• Device Lot Number: 5700022
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/22/2018