MAUDE Adverse Event Report: COVIDIEN LP HAWKONE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-M

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2019

Event Type  malfunction  

Event Description

While using the hawkone in this peripheral procedure, when trying to remove this equipment from the patient's left superficial femoral artery, the tip of the hawkone remained inside the patient.Dr.Proceeded to retrieve the tip utilizing a snare.He was able to snare the tip of the hawkone inside the sheath and pull the tip out of the sheath by pulling the spiderx filter out.Tip of the hawkone was intact upon removal.Patient was not harmed.Procedure completed.

• Brand Name: HAWKONE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): COVIDIEN LP; 444 mcdonnell blvd.; hazelwood MO 63042
• MDR Report Key: 8960053
• MDR Text Key: 156436834
• Report Number: 8960053
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H1-M
• Device Lot Number: 0009290631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA