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

Model Number	400SMTHXSFT0202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2020
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: 1.3005168196-2020-00693 2.3005168196-2020-00694 3.3005168196-2020-00696.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using penumbra smart coils (smart coils) and penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil to the target vessel.While attempting to detach the smart coil using the handle, the smart coil failed to detach; therefore, the smart coil was removed, and the handle was not used for the remainder of the procedure.The physician then advanced another smart coil to the vessel and attempted to detach it using another handle, but the same issue occurred; therefore, the second smart coil was removed, and the physician decided not to use the second handle.The procedure was completed using other non-penumbra coils (optima).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, 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: 1.3005168196-2020-00693, 2.3005168196-2020-00694, 3.3005168196-2020-00696 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
• MDR Report Key: 10099884
• Report Number: 3005168196-2020-00695
• Device Sequence Number: 14355260
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020
• 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: 09/23/2023
• Device Model Number: 400SMTHXSFT0202
• Device Catalogue Number: 400SMTHXSFT0202
• Device Lot Number: F86040
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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