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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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: 3005168196-2021-00614, 3005168196-2021-00615, 3005168196-2021-00617.
Event or Problem Description
The patient was undergoing a coil embolization procedure using smart coils.During the procedure, four smart coils would not advance within their respective introducer sheaths; therefore the smart coils were removed.The procedure was completed using other smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink and fracture observed near the pusher assembly mid-joint.Further evaluation revealed that the embolization coil was detached from the pusher assembly inside the introducer sheath.This damage was incidental to the reported complaint and likely occurred due to the separation of the pusher assembly fractured segments.Evaluation of the second returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be experienced during advancement.Forceful advancement against this resistance will result in offset coil wind on the embolization coil.During the functional test, resistance was encountered while attempting to advance the pusher assembly through the introducer sheath due to the offset coil winds on the proximal end of the embolization coil, and the pusher assembly could be advanced any further.Further evaluation revealed a kink in the pusher assembly.This damage is incidental to the reported complaint and likely occurred due to forceful advancement against resistance.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.This report is associated with mfr report numbers: 3005168196-2021-00614; 3005168196-2021-00615; 3005168196-2021-00617.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11582664
• Report Number: 3005168196-2021-00616
• Device Sequence Number: 17217456
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 03/02/2021
• 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: 04/30/2023
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F83135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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