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

Model Number	400SMTXSFT0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
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.This report is associated with mfr report numbers: 3005168196-2021-00163, 3005168196-2021-00165.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils), a smart coil detachment handle (handle), a benchmark 6f 071 delivery catheter (benchmark), and a non-penumbra microcatheter.During the procedure, the physician placed a smart coil in the target vessel using a microcatheter.The physician then advanced another smart coil into the target vessel and used the handle to detach it; however, the smart coil failed to detach.Therefore, the smart coil was removed.Next, the physician advanced another smart coil into the target vessel and used the handle to detach it.Subsequently, while retracting the pusher wire, the physician noticed that the smart coil had not detached.Therefore, the physician re-advanced the smart coil and attempted to manually detach the smart coil; however, it would not detach.Therefore, the smart coil was removed.The procedure was completed by relieving tension on the tip of the microcatheter and placing three other coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil confirmed that the pet lock was separated on the proximal end of the pusher assembly, and the embolization coil was intact with the pusher assembly.Further evaluation revealed that a section of the coated braided shaft was damaged.If the braided shaft is damaged, the pusher assembly braided shaft may compress when the pull wire is retracted.During functional testing, the smart coil was attempted to be detached with the returned handle, but the braided distal shaft compressed, and the embolization coil remained intact.The root cause of the braided shaft damage could not be determined.Evaluation of the second returned smart coil confirmed that the pet lock was separated on the proximal end of the pusher assembly, and the embolization coil was intact with the pusher assembly.Further evaluation revealed damage along the length of the braided distal shaft.The root cause of this damage could not be determined; however, this damage may have contributed to the inability to detach the smart coil during the procedure.Evaluation of the returned handle revealed an undamaged and functional device.During functional testing, the handle was tested on a handle test fixture and performed within specification.The handle was also used to detach the second returned smart coil without an issue.Evaluation of the returned non-penumbra device revealed a damage on the distal end.The root cause of this damage could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% visually inspected and functionally tested during incoming quality 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 damage along the length of the braided distal shaft.This report is associated with mfr report numbers: 3005168196-2021-00163.3005168196-2021-00165.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11228320
• Report Number: 3005168196-2021-00164
• Device Sequence Number: 14382043
• Product Code: HCG
• UDI-Device Identifier: 00814548015262
• UDI-Public: 00814548015262
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020
• 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: 11/20/2021
• Device Model Number: 400SMTXSFT0202
• Device Catalogue Number: 400SMTXSFT0202
• Device Lot Number: F72174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005