MAUDE Adverse Event Report: COOK INCORPORATED FEMORAL ARTERY PRESSURE MONITORING SET; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	G01909
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to place femoral arterial line in left groin.While attempting, the guide wire broke and a partial tip was left in the tissue.

• Brand Name: FEMORAL ARTERY PRESSURE MONITORING SET
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7510949
• Report Number: 7510949
• Device Sequence Number: 19229970
• Product Code: DQO
• UDI-Device Identifier: 00827002019096
• UDI-Public: (01)00827002019096
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018
• Report Date (Section F): 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: G01909
• Device Catalogue Number: C-PMS-400-FA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Date Report Sent to FDA: 04/10/2018