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

Model Number	400SMTXSFT0304
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
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: 1.3005168196-2021-02593.
Event or Problem Description
The patient was undergoing a stent-assisted coiling embolization procedure in the right anterior communicating artery (aca) using penumbra smart coils (smart coils), and a non-penumbra microcatheter.During the procedure, a smart coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using five additional smart coils and the same microcatheter.It was also reported that a periprocedural aneurysm rupture occurred, resulting in bleeding and causing patient expiration.However, the cause of the aneurysm rupture is unknown.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 18 nov 21: 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b.Box 5.Describe event or problem.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then, the smart coil was able to advance through the introducer sheath without an issue.Further evaluation revealed pusher assembly kinks.This damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a stent-assisted coiling embolization procedure in the right anterior communicating artery (aca) using penumbra smart coils (smart coils), and a non-penumbra microcatheter.During deployment of the second smart coil, an aneurysm rupture and a subarachnoid hemorrhage (sah) occurred.Subsequently, a balloon catheter was introduced to stop the bleeding.The coiling microcatheter was removed and a stenting microcatheter was introduced from the left internal carotid artery (ica) in the aca a2 segment.An aneurysm bridging stent was deployed into the left a1 segment without complications.While attempting to advance another smart coil, the coil would not advance past its initial position within its introducer sheath.Therefore, the smart coil was removed.A total of five smart coils and the same microcatheter were used to successfully complete the procedure.There were no reported technical complications during use of the smart coils.It was reported that the patient expired due to the aneurysm rupture and subsequent sah.However, the relationship between the sah and use of the smart coil is unknown.

• 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: 12833308
• Report Number: 3005168196-2021-02563
• Device Sequence Number: 14561489
• Product Code: HCG
• UDI-Device Identifier: 00814548015347
• UDI-Public: 00814548015347
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021
• 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: 12/16/2025
• Device Model Number: 400SMTXSFT0304
• Device Catalogue Number: 400SMTXSFT0304
• Device Lot Number: F102849
• Was Device Available for Evaluation?: Yes
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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: 46 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005