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

Model Number	400SMTXSFT0204
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 right middle cerebral artery (mca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), and non-penumbra microcatheter.During the procedure, the physician advanced a smart coil into the aneurysm using the microcatheter and attempted to detach the smart coil using the handle.The physician verified that the black alignment marker on the pusher assembly was separated and proceeded to pull the pusher assembly out under fluoroscopy.However, the handle failed to detach smart coil, and the smart coil came back with the pusher assembly.The physician then attempted to position the smart coil back into the aneurysm but was not successful.Therefore, the smart coil was removed.The procedure was completed using another smart coil and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated approximately 0.2 cm from the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 26.0, 47.0, 71.0 cm and 117.0 cm from the proximal end.The pull wire was within the capture feature of the pusher assembly distal detachment tip (ddt) and the embolization coil was intact with the pusher assembly.The embolization coil had offset coil winds along its length.Conclusions: evaluation of the returned smart coil revealed that the pet lock was separated at the proximal end of the pusher assembly, the pull wire was within its capture feature of the ddt, and the embolization coil was intact with the pusher assembly.If the handle used in the procedure is not properly seated on the pusher assembly prior to actuation, the pet lock may not separate far enough to retract the pull wire from the ddt and the embolization coil may not be detached from the pusher assembly.During functional testing, a demonstration handle was able to detach the returned smart coil without an issue.Further evaluation of the device revealed kinks on the pusher assembly and offset coil winds along the length of the embolization coil.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10348550
• Report Number: 3005168196-2020-01067
• Device Sequence Number: 2624419
• Product Code: HCG
• UDI-Device Identifier: 00814548015286
• UDI-Public: 00814548015286
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 07/08/2020
• 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: 01/15/2025
• Device Model Number: 400SMTXSFT0204
• Device Catalogue Number: 400SMTXSFT0204
• Device Lot Number: F95640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 09/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005