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

Model Number	400SMTSFT4H10
Medical Device Problem Code	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	11/02/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in a neurovascular artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician experienced resistance in the friction lock of the smart coil and as the smart coil was advanced through the microcatheter.Therefore, the smart coil was removed and placed on the back table.The procedure was completed using two new smart coils.It is unknown if the same microcatheter was used to complete the procedure.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 pusher assembly was kinked approximately 133.0 and 141.5 cm from the proximal end.The introducer sheath was loaded backwards onto the smart coil.The introducer sheath was fractured approximately 2.5 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned smart coil revealed that the introducer sheath was loaded backwards onto the smart coil and was fractured, the pusher assembly had kinks and the embolization coil had offset coil winds along its length.If the introducer sheath is loaded backwards onto the smart coil, resistance may be experienced while advancing the embolization coil and pusher assembly mid-joint through the introducer sheath friction lock.If the smart coil is forcefully advanced against this resistance, damage such as a fractured introducer sheath, pusher assembly kinks and offset coil winds may occur.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10908440
• Report Number: 3005168196-2020-02109
• Device Sequence Number: 1153951
• Product Code: HCG
• UDI-Device Identifier: 00814548017051
• UDI-Public: 00814548017051
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 11/02/2020
• 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: 08/11/2025
• Device Model Number: 400SMTSFT4H10
• Device Catalogue Number: 400SMTSFT4H10
• Device Lot Number: F99519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005