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

Model Number	400SMTHXSFT0102
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
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: 3005168196-2021-02754.3005168196-2021-02755.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, a non-penumbra guide catheter, a non-penumbra stent, and a non-penumbra balloon catheter.It was noted that the patient anatomy was tortuous, narrowed, and calcified.During the procedure, the physician placed three smart coils in the target vessel using the microcatheter.The physician then placed a stent through a balloon catheter in the target location.Next, the physician advanced a new smart coil through the expanded stent via the balloon catheter to the target location and attempted to detach it using two different handles; however, the smart coil failed to detach.Therefore, the smart coil was removed.The procedure was completed using three other coils, the same microcatheter, the same guide catheter, and the same balloon catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil would not detach from its pusher assembly.Evaluation revealed that the pet lock was separated, the pull wire was within the pusher assembly ddt and the embolization coil was intact and had offset coil winds.During functional testing, the smart coil was attempted to be detached using the returned handle but was unsuccessful.The pull wire did not retract out of the ddt and the pusher assembly distal flexible shaft began to compress.The cause of this damage could not be determined.Evaluation of the returned handle revealed an undamaged, functional device.The handle was tested on a handle test fixture and performed within specification.The handle was used to detach a demonstration smart coil without an issue.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 detachment issue.This report is associated with mfr report numbers: 1.3005168196-2021-02754, 2.3005168196-2021-02755.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12934631
• Report Number: 3005168196-2021-02753
• Device Sequence Number: 4787332
• Product Code: HCG
• UDI-Device Identifier: 00814548015613
• UDI-Public: 00814548015613
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022
• 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: 11/23/2025
• Device Model Number: 400SMTHXSFT0102
• Device Catalogue Number: 400SMTHXSFT0102
• Device Lot Number: F102263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005