MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA, INC SEPARATOR 8; CATHETER, EMBOLECTOMY

Model Number SEPARATOR 8

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2019

Event Type  Injury  

Event Description

Indigo system, separator 8 was used during an emergency pulmonary thrombectomy.During the procedure, wire tip broke off and became dislodged in the pulmonary artery.Fda safety report id# (b)(4).

• Brand Name: PENUMBRA, INC SEPARATOR 8
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): PENUMBRA, INC. ; alameda CA 94502
• MDR Report Key: 8604591
• MDR Text Key: 145022235
• Report Number: MW5086567
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/08/2019

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 Expiration Date: 12/19/2021
• Device Model Number: SEPARATOR 8
• Device Lot Number: F87602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2019
• 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): Disability
• Patient Age: 47 YR
• Patient Weight: 113