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

Model Number	400SMTHXSFT1H03
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00137.
Event or Problem Description
On (b)(6) 2020, the patient underwent a coil embolization procedure in the anterior cerebral artery (aca) and anterior communicating artery (acom) using penumbra smart coils (smart coils), a non-penumbra microcatheter and glide catheter.During the procedure, the physician administered aspirin to the patient.The left internal carotid artery (ica) was selected using the glide catheter.The ica revealed a left aca a1 occlusion and left aca pericallosal artery coil migration.Due to the complex aneurysm and established left frontal intraventricular hemorrhage, the decision was made to avoid retrieving the migrated smart coil.This event is ongoing.The coil migration was reported to be a serious adverse event with a possible relationship to the smart coil and a definite relationship to the index procedure.The physician continued with the procedure.The fifth smart coil was noticed to be kinked upon removal from the hoop.The damage to the smart coil was found prior to use, and the smart coil was not used in the procedure.Subsequently, the physician experienced difficulty advancing next smart coil in the introducer sheath, and the smart coil was removed.The procedure was completed successfully as the physician accessed the daughter sac of the aneurysm and coiled it.It was reported the patient had an external ventricular drain (evd) removed and no spasm.
Additional Manufacturer Narrative
Please note that the following section has been updated based on additional information provided by the penumbra clinical team on 01/14/2021: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink and fracture observed near the mid-joint.Further evaluation revealed that the embolization coil was detached from the pusher assembly.This damage was likely a result of the pusher assembly fracture.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2021-00137.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) and anterior communicating artery (acom) using penumbra smart coils (smart coils), a non-penumbra microcatheter and glide catheter.During the procedure, a smart coil was noticed to be kinked upon removal from the hoop.The damage to the smart coil was found prior to use, and the smart coil was not used in the procedure.The physician then experienced difficulty advancing a new smart coil in the introducer sheath; therefore, the smart coil was removed from the patient.The physician placed four smart coils in the aneurysm lumen.It was noted that a coil migrated into the left aca.Due to the complex aneurysm and established left frontal intraventricular hemorrhage, the decision was made to avoid retrieving the migrated smart coil.This event is ongoing.The coil migration was reported to be a serious adverse event with a possible relationship to the smart coil and a definite relationship to the index procedure.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11206187
• Report Number: 3005168196-2021-00136
• Device Sequence Number: 14295872
• Product Code: HCG
• UDI-Device Identifier: 00814548015668
• UDI-Public: 00814548015668
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020
• 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: 10/27/2021
• Device Model Number: 400SMTHXSFT1H03
• Device Catalogue Number: 400SMTHXSFT1H03
• Device Lot Number: C17896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005