MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTXSFT2H04

Device Problems Migration (4003); Difficult or Delayed Separation (4044)

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

Event Date 07/17/2022

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the left anterior communicating artery (acom).Using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), benchmark 6f 071 delivery catheter (benchmark), and a non-penumbra microcatheter.During the procedure, the physician was advancing the smart coil into the target location using the microcatheter; however, after the smart coil had partially entered the aneurysm, the microcatheter kicked back out.The physician repositioned the microcatheter and, then decided to remove and replace the smart coil with a smaller size smart coil.Next, the physician advanced the new smart coil into the aneurysm and attempted to detach it using a handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil, but the attempt was unsuccessful.Therefore, the physician removed the handle and detached the smart coil using a new handle.Upon removing the pusher assembly of the smart coil, approximately one millimeters of the tail of the detached smart coil came out of the aneurysm and was left in the parent vessel.Subsequently, the physician inserted the next smart coil into the microcatheter and advanced the coil to push the tail of the previous smart coil that was left in the parent vessel back into the aneurysm.The smart coil was then detached using the handle.Afterwards, the physician advanced a third smart coil into aneurysm and attempted to detach it using the handle; however, the smart coil would not detach.The physician removed the handle and used a new handle to detach the smart coil.A fourth smart coil was then advanced behind the previous smart coil to push both coils into the aneurysm; however, the smart coil would not detach using the handle.Therefore, the physician manually detached the smart coil, and the coil was successfully implanted.The procedure had ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15157619
• MDR Text Key: 297452918
• Report Number: 3005168196-2022-00368
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 814548015323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/03/2022

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 Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F111791
• 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: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/17/2022
• Initial Date FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female