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

Model Number 400SMTXSFT4H12

Device Problem Separation Failure (2547)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

The coil would not detach after placement into the patient.The coil was removed without incident or harm.Manufacturer response for coil, penumbra smart coil 4.5/12 extra soft (per site reporter).Clinical site reported to the manufacturer directly.

• Brand Name: SMART COIL
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): PENUMBRA, INC.; 630 roseville parkway; roseville CA 95747
• MDR Report Key: 14407045
• MDR Text Key: 291715875
• Report Number: 14407045
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 400SMTXSFT4H12
• Device Lot Number: F100764
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other