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

Catalog Number	400SMTHXSFT0510
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	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2019-01488, 3005168196-2019-01489, 3005168196-2019-01490.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the diverticulum of the sigmoid sinus using penumbra smart coils (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician successfully placed a smart coil in the target vessel using a non-penumbra microcatheter and detached it using a handle, however, the pusher assembly became stuck in the handle and, therefore, both the handle and pusher assembly were removed.Next, the physician met resistance and was unable to advance a new smart coil into the microcatheter; therefore, the smart coil was re-sheathed and saved for later use.The physician then attempted to advance another new smart coil; however, the same resistance issue occurred, and the smart coil was also re-sheathed and saved for later use.It was reported that the physician noticed a piece of the pusher assembly was stuck inside of the microcatheter, and therefore, a non-penumbra guidewire was advanced through the microcatheter to push any material into the diverticulum.The physician then advanced the same smart coils that had been re-sheathed and saved for later use through the same microcatheter, and successfully detached both using a new handle to complete the procedure.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8858018
• Report Number: 3005168196-2019-01491
• Device Sequence Number: 2494604
• Product Code: HCG
• UDI-Device Identifier: 00814548015859
• UDI-Public: 00814548015859
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2019
• 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: 11/11/2023
• Device Catalogue Number: 400SMTHXSFT0510
• Device Lot Number: F86993
• Was Device Available for Evaluation?: No
• 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: 07/03/2019
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005