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	09/16/2020
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 the upper ocular venous using penumbra smart coils (smart coils) and a non-penumbra microcatheter.It was noted that the patient's anatomy was tortuous.During the procedure, the physician implanted twenty-four coils in the target vessel, including five smart coils.While attempting to advance a new smart coil out in its introducer sheath and into the microcatheter, the physician experienced resistance and was unable to advance the smart coil past the rotating hemostasis valve (rhv) of the microcatheter.It was reported that the distal tip of the smart coil was located in the rhv.Therefore, the smart coil was removed.The procedure was completed using five smart coils, four other 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was kinked approximately 31.0, 60.0, 118.0, 143.0 and 144.0 cm from the proximal end.The pusher assembly mid-joint was retracted through the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.The non-penumbra microcatheter was undamaged.Conclusions: evaluation of the returned smart coil could not confirm the reported complaint.During functional testing, the smart coil was advanced through the returned non-penumbra microcatheter with resistance due to kinks in the pusher assembly.The root cause of the initial resistance experienced during the procedure could not be determined.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and pusher assembly kinks.This damage was likely incidental to the reported complaint and may have occurred after removal from the procedure.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the initial resistance experienced during the procedure.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: 10659908
• Report Number: 3005168196-2020-01706
• Device Sequence Number: 3552118
• 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): 09/17/2020
• 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: 09/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 10/10/2020
• Supplement Report FDA Received Date: 12/24/2020
• 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