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

Model Number	400SMTHXSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils (smart coil), non-penumbra coils and a non-penumbra microcatheters.It was noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted two smart coils and six non-penumbra coils in the target vessel.Next, the physician attempted to advance another smart coil, however, the smart coil was stuck within its introducer sheath.Therefore, the smart coil was removed.It was reported that the introducer sheath of the smart coil was flushed before it was inserted into the microcatheter.The procedure was completed using two additional smart coils, two non-penumbra coils and the same microcatheter.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Results: the pet lock was separated on the proximal end of the pusher assembly.The pull wire was retracted form the pusher assembly distal detachment tip (ddt), and the embolization coil was detached from the pusher assembly.The embolization coil had offset coil winds along its length.The device was returned outside of the introducer sheath.Conclusions: evaluation of the returned smart coil revealed that the device was returned outside of the introducer sheath.Further evaluation of the device revealed that the pet lock was separated, and the embolization coil was detached from the pusher assembly and had offset coil winds along its length.This damage was likely incidental to the complaint.The smart coil was unable to be functionally tested; therefore, the reported complaint could not be confirmed.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the smart coil being stuck within its introducer sheath.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.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: 10759428
• Report Number: 3005168196-2020-01843
• Device Sequence Number: 19648739
• Product Code: HCG
• UDI-Device Identifier: 00814548015781
• UDI-Public: 00814548015781
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 09/30/2020
• 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: 01/25/2025
• Device Model Number: 400SMTHXSFT0306
• Device Catalogue Number: 400SMTHXSFT0306
• Device Lot Number: F95786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 01/14/2005; 11/09/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 10/31/2020; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Date Report Sent to FDA: 01/01/2005