MAUDE Adverse Event Report: MEDTRONIC, INC. DIRECTIONAL ATHERECTOMY SYSTEM WITH CATHETER LARGE VESSEL STANDARD TIP; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number REF H1-14550

Device Problem Misconnection (1399)

Patient Problem No Information (3190)

Event Date 12/19/2018

Event Type  Injury  

Event Description

Device did not engage.No pt harm associated with event.

• Brand Name: DIRECTIONAL ATHERECTOMY SYSTEM WITH CATHETER LARGE VESSEL STANDARD TIP
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC, INC. ; minneapolis MN 55432
• MDR Report Key: 8270873
• MDR Text Key: 134006049
• Report Number: MW5083297
• Device Sequence Number: 0
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: REF H1-14550
• Device Catalogue Number: H1-LS
• Device Lot Number: 0009340612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR