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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
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: 3005168196-2020-01384, 3005168196-2020-01385, 3005168196-2020-01386, 3005168196-2020-01388, 3005168196-2020-01389, 3005168196-2020-01390.
Event or Problem Description
The patient was undergoing a coil embolization procedure for an arteriovenous malformation (avm) using penumbra smart coils (smart coils), penumbra smart coil detachment handle (handle), a benchmark 6f 071 delivery catheter (benchmark), and non-penumbra microcatheter.During the procedure, the physician advanced five smart coils separately into the avm and clicked on the handle.It was reported that the physician switched to a second handle after experiencing this issue with two to three smart coils; however, the second handle failed to detach the remaining smart coils.The pusher assembly of each smart coil indicated the smart coil was detached correctly, but both handle failed to detach five smart coils.Therefore, the smart coils and handle were removed.The procedure was completed using non-penumbra smart coils.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 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: 1.3005168196-2020-01384, 2.3005168196-2020-01385, 3.3005168196-2020-01386, 4.3005168196-2020-01388, 5.3005168196-2020-01389, 6.3005168196-2020-01390.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10497003
• Report Number: 3005168196-2020-01387
• Device Sequence Number: 2687546
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020
• 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: 04/27/2025
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F97574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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