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

Model Number	400SMTXSFT3H06
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
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: 3005168196-2020-01452, 3005168196-2020-01453, 3005168196-2020-01454, 3005168196-2020-01455, 3005168196-2020-01456, 3005168196-2020-01457.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, a smart coil would not advance in the introducer sheath and was stuck at the initial position.The smart coil was removed.The physician continued with the procedure using another smart coil.However, the same issue occurred, and the second smart coil was removed.Subsequently, the physician advanced four smart coils individually to the target vessel.The handle took two to three attempts to detach the first, second, and third smart coils, and the handle was unable to detach the fourth smart coil.Therefore, the physician used a hemostat to manually detach the fourth smart coil.The procedure was completed using additional smart coils and another handle.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 embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed an undamaged and a functional device.During functional testing, the smart coil was able to advance through its introducer sheath and a demonstration microcatheter without an issue.The reported complaint could not be confirmed.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forcefully advancing the device against this resistance may have contributed to the kinks which were observed on the pusher assembly.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.Then the device was able to advance through its introducer sheath and a demonstration microcatheter with resistance due to the kinks on the pusher assembly.Evaluation of the returned handle revealed an undamaged and a functional device.During functional testing, the handle was tested with a handle test fixture and performed within specification.The handle was able to detach a demonstration smart coil without an issue.The reported complaint could not be confirmed.Penumbra coils and handles 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 numbers: 3005168196-2020-01452, 3005168196-2020-01453, 3005168196-2020-01454, 3005168196-2020-01455, 3005168196-2020-01456, 3005168196-2020-01457.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10522644
• Report Number: 3005168196-2020-01451
• Device Sequence Number: 3624498
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• 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): 08/17/2020
• 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: 07/01/2023
• Device Model Number: 400SMTXSFT3H06
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F84423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005