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

Model Number	400SMTXSFT2H04
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, it was reported that a smart coil ¿detached, but not properly¿.No further information is available.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned smart coil revealed that the pet lock was separated on the proximal end of the pusher assembly.If the pet lock is separated and retracted on the proximal end, the embolization coil will become detached.Based on the returned device, the embolization coil was detached properly.The root cause of the reported event was unable to be determined.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10150933
• Report Number: 3005168196-2020-00771
• Device Sequence Number: 13976713
• Product Code: HCG
• UDI-Device Identifier: 00814548015323
• UDI-Public: 00814548015323
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 05/20/2020
• 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: 06/24/2024
• Device Model Number: 400SMTXSFT2H04
• Device Catalogue Number: 400SMTXSFT2H04
• Device Lot Number: F91352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 10/21/2020
• 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