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

Model Number 400SMTSFT0610

Device Problems Separation Failure (2547); Unintended Movement (3026); Migration (4003); Difficult or Delayed Separation (4044)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle), a non-penumbra microcatheter, and a guidewire.During the procedure, the physician successfully implanted four smart coils in the target vessel using the handle.Then, the physician advanced three smart coils (f106492, f106751, and f106751) to the target vessel using the microcatheter and attempted to detach them using a handle; however, the smart coils failed to detach.It was reported that attempts were made to detach the smart coils using a second handle; however, they were unsuccessful.The physician then attempted to manually detach the smart coils using a hemostat; however, it was also unsuccessful.Therefore, the smart coils were removed.Then, the physician advanced the next smart coil (f86218) to the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.Subsequently, the physician manually detached the smart coil.However, upon retracting the microcatheter from the aneurysm, the smart coil came out of the aneurysm.Therefore, the physician advanced a shorter smart coil to the target vessel to push the previously detached smart coil back into the aneurysm, and subsequently, the physician retracted and removed the shorter smart coil.Next, the physician successfully implanted seven smart coils in the target vessel using a handle.While attempting to advance another smart coil (f100753) to the target vessel, the smart coil would not advance out of its introducer sheath.Therefore, the smart coil was removed.Then, the physician successfully implanted another smart coil in the target vessel using a handle.While attempting to advance the next smart coil (f106600) to the target vessel, the smart coil also would not advance out of its introducer sheath.Therefore, the smart coil was also removed.Then, the physician successfully implanted the next smart coil in the target vessel using a handle.While attempting to detach another smart coil (f107389) in the target vessel using a handle, the smart coil also failed to detach.Subsequently, the physician manually detached the smart coil.However, upon retracting the microcatheter from the aneurysm, the smart coil came out of the aneurysm.Therefore, the physician advanced a shorter smart coil to the target vessel to push the previously detached smart coil back into the aneurysm, and subsequently, the physician retracted and removed the shorter smart coil.The procedure was completed at this point.It was also reported it is unknown which handle was used to complete the procedure.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.This report is associated with mfr report number: 3005168196-2021-02806.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up report: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Device code 1, 2, and 3.Please note that the device in complaint was not expected to be returned; however, on 11/30/2021 the device was received.Evaluation of the returned smart coil revealed that the embolization coil was detached from its pusher assembly.This coil was detached and implanted in the patient according to the complaint.Therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed multiple kinks throughout the length of the pusher assembly.This damage was incidental to the reported complaint.Penumbra products are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and functionally tested during incoming inspection by quality.This report is associated with mfr report number: 1.3005168196-2021-02806.H3 other text : placeholder.

Event Description

The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coil), penumbra smart coil detachment handles (handle), a non-penumbra microcatheter (sl-10), and a guidewire.During the procedure, the physician successfully implanted four smart coils in the target vessel using the handle.Then, the physician advanced three smart coils (f106492, f106751, and f106751) to the target vessel using the microcatheter and attempted to detach them using a handle; however, the smart coils failed to detach.It was reported that attempts were made to detach the smart coils using a second handle; however, they were unsuccessful.The physician then attempted to manually detach the smart coils using a hemostat; however, it was also unsuccessful.Therefore, the smart coils were removed.Then, the physician advanced the next smart coil (f86218) to the target vessel and attempted to detach it using a handle; however, the smart coil failed to detach.The physician attempted to manually detach the smart coil; however, was unsuccessful.Upon retracting the microcatheter from the aneurysm, the smart coil also advanced into the microcatheter.The smart coil then unintentionally detached within the microcatheter.Therefore, the physician advanced a shorter smart coil to the target vessel to push the previously detached smart coil back into the aneurysm.The physician then retracted and removed the shorter smart coil from the patient.Next, the physician successfully implanted seven smart coils in the target vessel using a handle.While attempting to advance another smart coil (f100753) to the target vessel, the smart coil would not advance out of its introducer sheath.Therefore, the smart coil was removed.Then, the physician successfully implanted another smart coil in the target vessel using a handle.While attempting to advance the next smart coil (f106600) to the target vessel, the smart coil also would not advance out of its introducer sheath.Therefore, the smart coil was also removed.Then, the physician successfully implanted the next smart coil in the target vessel using a handle.While attempting to detach another smart coil (f107389) in the target vessel using a handle, the smart coil also failed to detach.The physician attempted to manually detach the smart coil.However, upon retracting the microcatheter from the aneurysm, the smart coil also advanced into the microcatheter.The smart coil then unintentionally detached within the microcatheter.Therefore, the physician advanced a shorter smart coil to the target vessel to push the previously detached smart coil back into the aneurysm.The physician then retracted and removed the shorter smart coil from the patient.The procedure was completed at this point.It was also reported it is unknown which handle was used to complete the procedure.There was no report of an adverse effect to the patient.

• 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: 13130516
• MDR Text Key: 287201026
• Report Number: 3005168196-2021-02805
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014968
• UDI-Public: 00814548014968
• 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,Followup
• Report Date: 01/01/2005,03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 400SMTSFT0610
• Device Catalogue Number: 400SMTSFT0610
• Device Lot Number: F86218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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: 63 YR
• Patient Sex: Female