MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA PACKING COIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Lot Number F00002478

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  Injury  

Event Description

Penumbra embolization coils were used during the case.Multiple coils were deployed.At one point during the case, one of the coils (a penumbra 5 cm packing coil) was deployed and as the interventional radiologist was taking out the deployment device, he saw something wasn't right.Part of the metal casing was missing.Immediately, he checked on imaging to see where the casing was.It was not in the patient's body.The micro catheter (a penumbra 45d lantern) was pulled out of the body and the metal cases was felt inside the device.This was removed from the table.A new micro catheter was placed on the table and embolization continued as normal.Another embolization coil (a penumbra 15 cm packing coil) was advanced into the body a little while later.It took much manipulation to try to get it to bunch up the way the radiologist wanted.During the manipulation, it appeared that the coil self-deployed and released itself from the deployment device.Deployment device was removed, and a coil pusher wire was used to finish placing the coil in the intended vessel.Penumbra medical representative was called during the case to inform him of the two faulty coils.The rest of the procedure ran smoothly and without incident.Fda safety report id # (b)(4).

• Brand Name: PENUMBRA PACKING COIL
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; alameda CA 94502
• MDR Report Key: 15659028
• MDR Text Key: 302345844
• Report Number: MW5112797
• Device Sequence Number: 1
• Product Code: HCG
• 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: 10/19/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: F00002478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: Black Or African American