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

Model Number	400SMTXSFT0208
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	11/09/2020
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: 3005168196-2020-02202.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right renal artery using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous and narrowed.During the procedure, the physician placed a smart coil into the target vessel using the microcatheter.While advancing another smart coil through the middle of the microcatheter, the physician experienced resistance.Therefore, the smart coil was removed.Afterwards, the physician advanced a new smart coil through the microcatheter; however, the same issue occurred.Therefore, the smart coil was removed.The procedure was completed using one smart coil, two 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 pusher assembly was kinked in multiple locations throughout its length.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance maybe experienced.Further advancement against this resistance may result in offset coil winds.During the functional test, resistance was encountered while attempting to advance the smart coil through its introducer sheath due to offset coil winds on the proximal end of the embolization coil, and the smart coil could not be advanced at all.Evaluation of the second returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance maybe experienced.Further advancement against this resistance may result in offset coil winds.During the functional test, resistance was encountered while attempting to advance the smart coil through a demonstration microcatheter due to the offset coil winds bunching up inside the hub of the microcatheter, and the smart coil could not be advanced any further.Penumbra coils are visually 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: 3005168196-2020-02202.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10955315
• Report Number: 3005168196-2020-02201
• Device Sequence Number: 2177747
• Product Code: HCG
• UDI-Device Identifier: 00814548015552
• UDI-Public: 00814548015552
• 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): 11/10/2020
• 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: 12/01/2024
• Device Model Number: 400SMTXSFT0208
• Device Catalogue Number: 400SMTXSFT0208
• Device Lot Number: F94584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005