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

Model Number	400SMTSFT0306
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coils), a penumbra smart coil handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully placed a smart coil in the target vessel using the microcatheter.The physician then advanced the next smart coil into the target vessel using the microcatheter and used the handle to detach it.While retracting the pusher assembly of the smart coil, the smart coil started to come back into the microcatheter, and the physician then realized that the smart coil was not detached.Subsequently, the physician made three attempts to detach the smart coil using the handle but was unsuccessful.Then after some manipulation, the physician was able to successfully detach the smart coil; however, a few millimeters of the proximal end of the detached smart coil were hanging out of the aneurysm.It was reported that it was not possible to advance the guidewire through the microcatheter to push the proximal end of the detached smart coil into the aneurysm due to an unknown material being inside the microcatheter.The microcatheter was then removed from the patient and flushed on the back table.The physician then used the stiffer proximal end of the guidewire to push through the microcatheter and the unknown material came out.Afterwards, the physician had difficulty re-gaining access of the target vessel using a second non-penumbra microcatheter.Subsequently, the microcatheter kicked back and ruptured the aneurysm.The ruptured aneurysm was quickly treated by using a balloon catheter and placing additional smart coils using the same handle.It was reported that the next smart coil failed to detach using the same handle after three attempts.Therefore, the smart coil was removed.The physician continued the procedure using additional smart coils and the same handle.An angiography was then performed, and it was noticed that the few millimeters of the proximal end of the previously detached smart coil were no longer hanging out of the aneurysm.It was also reported that after the second microcatheter was removed and flushed, some unknown material came out.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional 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.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra sales representative on 13-jun-2022: 1.Section b.Box 5.Describe event or problem h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coils), a penumbra smart coil handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully placed a smart coil in the target vessel using the microcatheter.The physician then advanced the next smart coil into the target vessel using the microcatheter and used the handle to detach it.While retracting the pusher assembly of the smart coil, the smart coil started to come back into the microcatheter, and the physician then realized that the smart coil was not detached.Subsequently, the physician made three attempts to detach the smart coil using the handle but was unsuccessful.Then after some manipulation, the physician was able to successfully detach the smart coil; however, a few millimeters of the proximal end of the detached smart coil were hanging out of the aneurysm.It was reported that it was not possible to advance the guidewire through the microcatheter to push the proximal end of the detached smart coil into the aneurysm due to an unknown material being inside the microcatheter.The microcatheter was then removed from the patient and flushed on the back table.The physician then used the stiffer proximal end of the guidewire to push through the microcatheter and the unknown material came out.Afterwards, the physician had difficulty re-gaining access of the target vessel using a second non-penumbra microcatheter.Subsequently, the microcatheter kicked back and ruptured the aneurysm.The ruptured aneurysm was quickly treated by using a balloon catheter and placing additional smart coils using the same handle.It was reported that the next smart coil failed to detach using the same handle after three attempts.Therefore, the smart coil was removed.An angiography was then performed, and it was noticed that the few millimeters of the proximal end of the previously detached smart coil were no longer hanging out of the aneurysm.It was also reported that after the second microcatheter was removed and flushed, some unknown material came out.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: 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: 14434915
• Report Number: 3005168196-2022-00219
• Device Sequence Number: 17537635
• Product Code: HCG
• UDI-Device Identifier: 00814548015040
• UDI-Public: 00814548015040
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022
• 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: 10/08/2025
• Device Model Number: 400SMTSFT0306
• Device Catalogue Number: 400SMTSFT0306
• Device Lot Number: F100960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005