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

Model Number	PND6F070956M
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
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: 3005168196-2019-01202, 3005168196-2019-01203, 3005168196-2019-01204.
Event or Problem Description
The patient was undergoing an embolization procedure in the posterior communicating artery (pcom) using a penumbra smart coils (smart coils) and pod5.During the procedure, while attempting to advance a smart coil within its introducer sheath, it got stuck; therefore, the smart coil was removed.The physician then experienced resistance while advancing the last 3 mm of the pod5 into the aneurysm and the microcatheter kicked back.Therefore, the pod5 was removed from the patient.The physician then advanced another smart coil into the aneurysm.The smart coil was detached using a penumbra smart coil detachment handle (handle); however, while retracting the pusher assembly of the smart coil, it was noted under fluoroscopy that the smart coil was not detached from the pusher assembly.The physician indicated that part of the smart coil remained within the microcatheter and part of the smart coil was still attached to the pusher assembly.The microcatheter was removed from the patient with the smart coil segment in it.The procedure was ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2019-01205.Section d.Box 4.Catalog #.Section d.Box 4.Unique identifier.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra distributor 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 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 number: 3005168196-2019-01202; 3005168196-2019-01203; 3005168196-2019-01204.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8724921
• Report Number: 3005168196-2019-01205
• Device Sequence Number: 11268230
• Product Code: HCG
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2019
• 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 Model Number: PND6F070956M
• Device Catalogue Number: SCH1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 01/14/2005; 12/18/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/19/2019; 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005