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

Model Number	400SMTXSFT0103
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a left side paraophthalmic aneurysm using a penumbra smart coil.During the procedure, a smart coil would not advance at all within its introducer sheath.Therefore, the smart coil was removed.The procedure was completed using a new coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds along the embolization coil.This type of damage typically occurs if the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement which creates resistance, and then the device is forcefully advanced.During the functional test, resistance was encountered while advancing the coil out of its introducer sheath due to the offset coil winds.After manipulating the coil within its introducer sheath against resistance, the coil was able to be advanced out.The smart coil was then attempted to be advance through a demonstration microcatheter and was unsuccessful due to the offset coil winds.Further evaluation revealed a kink in the pusher assembly.This damage was incidental to the reported complaint and likely occurred due to the forceful advancement against resistance.Penumbra coil 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: 11852447
• Report Number: 3005168196-2021-01108
• Device Sequence Number: 17085520
• Product Code: HCG
• UDI-Device Identifier: 00814548015194
• UDI-Public: 00814548015194
• Combination Product (Y/N): Y
• Initial Reporter Country: LE
• 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
• Report Date (Section B): 07/26/2021
• 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: 12/18/2021
• Device Model Number: 400SMTXSFT0103
• Device Catalogue Number: 400SMTXSFT0103
• Device Lot Number: F73219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005