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

Model Number	400SMTXSFT0308
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
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 number: 3005168196-2020-01847.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula (davf) using penumbra smart coils (smart coil), non-penumbra coils, and a non-penumbra microcatheter.During the procedure, the physician successfully placed two smart coils and a non-penumbra coil in the target vessel using the microcatheter.Next, the physician attempted to advance another smart coil; however, the smart coil was stuck within its introducer sheath and would not advance at all from its initial position.Therefore, the smart coil was removed.The physician then placed three additional smart coils in the vessel.The physician attempted to advance another smart coil through the introducer sheath; however, the same issue occurred; therefore, the smart coil was also removed.The procedure was completed using three additional smart coils, 20 non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was undamaged and intact with the pusher assembly.The pusher assembly mid-joint was returned retracted through the introducer sheath friction lock.The introducer sheath was fracture beneath the friction lock.Conclusions: evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock, and the introducer sheath was fractured.If the pusher assembly mid-joint is retracted through the introducer sheath friction lock, resistance may be experienced during advancement, and damage such as a fractured introducer sheath may occur.During functional testing, the smart coil was able to be advanced through the friction lock with resistance.After unseating the pusher assembly from the friction lock, the pusher assembly was advanced without issue.Evaluation of the second 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.Further evaluation revealed a pusher assembly kink near the mid-joint.This damage was likely a result of forceful advancement against resistance.During functional testing, the smart coil was able to be advanced through the friction lock with resistance.After unseating the pusher assembly from the friction lock, the pusher assembly was advanced without issue.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.This report is associated with mfr report number: 1.3005168196-2020-01847.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10759739
• Report Number: 3005168196-2020-01846
• Device Sequence Number: 16959359
• Product Code: HCG
• UDI-Device Identifier: 00814548015361
• UDI-Public: 00814548015361
• 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): 10/05/2020
• 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: 01/14/2024
• Device Model Number: 400SMTXSFT0308
• Device Catalogue Number: 400SMTXSFT0308
• Device Lot Number: F87945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005