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

Model Number G48004

Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/08/2021

Event Type  malfunction  

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12553719
• MDR Text Key: 274031378
• Report Number: 12553719
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480049
• UDI-Public: (01)00827002480049
• 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: 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
• Device Operator: Health Professional
• Device Model Number: G48004
• Device Catalogue Number: MPIS-401-10.0-SC-NT-U-SST
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2021
• Event Location: Other
• Date Report to Manufacturer: 09/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA