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

Model Number MPIS-501-10.0-SC-NT-U-SST

Device Problems Backflow (1064); Break (1069); Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/05/2017

Event Type  Injury  

Event Description

Cardiologist was called in during the middle of the night to place a temporary pacer for patient who was experiencing symptomatic bradycardia.Needle inserted into right internal jugular vein with draw back of blood; went to advance the wire; wire would not advance; went to remove the wire and there was resistance when trying to remove the wire; removed wire and needle; wire was unraveled; gained access again with micropuncture needle; new wire advanced; while advancing the temporary catheter, noticed something on the x-ray but unsure if it was something new or something from a past procedure; after catheter was placed and the questionable object was looked at.Procedure finished with new wire.Doctor believes the radio opaque, "soft cloth part" broke off from the original wire.Fluoro was obtain and the fragment was determined to be embedded in the dermal layer of the skin.Doctor consulted with other physicians who agreed it was not in the vasculature.Removed the fragment under later that day.The fragment was sent to pathology and is 1.2cm in length by 0.1cm in diameter.No injury to patient.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniel way; bloomington IN 47404
• MDR Report Key: 7178390
• MDR Text Key: 96848062
• Report Number: 7178390
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: MPIS-501-10.0-SC-NT-U-SST
• Device Catalogue Number: G48008
• Device Lot Number: 8189979
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2017
• Event Location: Other
• Date Report to Manufacturer: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR