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
Catheter kinked during procedure, unable to thread anything through it.

• 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: 7667602
• Report Number: 7667602
• Device Sequence Number: 1118498
• 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: 5600237
• 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: 07/06/2018
• 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