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

Catalog Number	400SMTXSFT0102
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a superior sagittal cavernous fistula using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully implanted three smart coils into the target vessel using the handle.Next, the physician advanced a new smart coil into the target vessel using the microcatheter and attempted to detach it using the handle; however, the smart coil failed to detach.Therefore, the physician decided to remove the smart coil.While retracting the smart coil, it unintentionally detached.Subsequently, the physician pushed the detached smart coil into the target vessel using the pusher assembly.The procedure was completed using two additional smart coils, the same handle, and the same microcatheter.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 was detached.Evaluation revealed that the pet lock and pusher assembly were fractured on the proximal end of the pusher assembly.This damage likely occurred due to the manual detachment attempted during the procedure.The pusher assembly had kinks and the pusher assembly was returned wrapped around itself.This damage was likely incidental to the reported complaint and occurred post-procedure during packaging for return to penumbra.Due to the return damage, the device was unable to be functionally tested, and therefore, the root cause of the reported complaint could not be determined.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.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16396733
• Report Number: 3005168196-2023-00077
• Device Sequence Number: 5543638
• Product Code: HCG
• UDI-Device Identifier: 00814548015187
• UDI-Public: 814548015187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023
• 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 Catalogue Number: 400SMTXSFT0102
• Device Lot Number: F00001844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005