MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Model Number	G48004
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While trying to access femoral artery for cardiac cath, tip of wire from micropuncture kit sheared off into subcutaneous tissue, physician present.

• Brand Name: MICROPUNCTURE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12553719
• Report Number: 12553719
• Device Sequence Number: 14478812
• Product Code: DYB
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/15/2021
• Report Date (Section F): 09/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: G48004
• Device Catalogue Number: MPIS-401-10.0-SC-NT-U-SST
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/15/2021