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

Model Number	400SMTXSFT0203
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2020
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.This report is associated with mfr report numbers: 3005168196-2020-00693.3005168196-2020-00694.3005168196-2020-00695.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coils (smart coils) and penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil to the target vessel.While attempting to detach the smart coil using the handle, the smart coil failed to detach; therefore, the smart coil was removed, and the handle was not used for the remainder of the procedure.The physician then advanced another smart coil to the vessel and attempted to detach it using another handle, but the same issue occurred; therefore, the second smart coil was removed, and the physician decided not to use the second handle.The procedure was completed using other non-penumbra coils (optima).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated approximately 0.2 cm apart on the proximal end of the pusher assembly.Kinks were present along the length of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the two returned handles revealed undamaged and functional devices.During functional testing, the handles were able to detach demonstration smart coils without issue.The smart coil was not returned for evaluation.Evaluation of the returned smart coil revealed that the pet lock was not separated far enough to retract the pull wire from the pusher assembly distal detachment tip to detach the embolization coil.During functional testing, the smart coil was unable to be detached with the returned handles and a demonstration handle due to the damages on its pusher assembly.Due to the returned condition of the smart coil, the root cause of the reported complaint was unable to be determined.Penumbra coils and handles are visually inspected and functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report numbers: 1.3005168196-2020-00693 2.3005168196-2020-00694 3.3005168196-2020-00695 h3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10099889
• Report Number: 3005168196-2020-00696
• Device Sequence Number: 19726011
• Product Code: HCG
• UDI-Device Identifier: 00814548015279
• UDI-Public: 00814548015279
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: 400SMTXSFT0203
• Device Catalogue Number: 400SMTXSFT0203
• Device Lot Number: F86584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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