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

Model Number	400SMTHXSFT0203
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-00625, 3005168196-2021-00626.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils), a smart coil detachment handle (handle), and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous and narrowed.During the procedure, the physician placed six non-penumbra coils into the target vessel using the microcatheter.Next, the physician advanced a smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the handle was removed.The physician then attempted to detach the smart coil using a new handle; however, the smart coil failed to detach.Therefore, the handle was removed.Subsequently, upon removal of the smart coil, the smart coil detached within the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed.Afterwards, a contrast run was performed that indicated that the target location was successfully embolized with the previously placed coils.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the pet lock was separated.This damage was likely a result of a coil detachment attempt during the procedure.The smart coil was stuck inside the non-penumbra microcatheter and unable to remove from the catheter.The embolization coil and the pusher assembly distal detachment tip were not visible inside the catheter; therefore, the reported smart coil detached within the microcatheter could not be confirmed.Based on the returned condition, the root cause of the reported complaint could not be determined.Evaluation of the returned handle revealed a functional and an undamaged device.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration smart coil without issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report numbers: 1.3005168196-2021-00625, and 2.3005168196-2021-00626.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11586637
• Report Number: 3005168196-2021-00624
• Device Sequence Number: 4296443
• Product Code: HCG
• UDI-Device Identifier: 00814548015705
• UDI-Public: 00814548015705
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: 400SMTHXSFT0203
• Device Catalogue Number: 400SMTHXSFT0203
• Device Lot Number: F84411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005