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

Model Number	400SMTXSFT0306
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
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 subarachnoid hemorrhage (sah) using a penumbra smart coil (smart coil), a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra microcatheter.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 non-penumbra coil, the same benchmark, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed that the device was returned advanced outside of its introducer sheath; therefore, the reported inability to advance the coil out of its introducer sheath could not be confirmed.Further evaluation revealed offset coil winds on the embolization coil.This damage was likely incidental to the reported complaint and may have occurred during packaging of return to penumbra.During functional testing, the smart coil was re-sheathed without an issue; subsequently, resistance was experienced while attempting to advance the smart coil within the introducer sheath due to the offset coil winds, and the smart coil could not advance any further.Penumbra coils are 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: 11852450
• Report Number: 3005168196-2021-01109
• Device Sequence Number: 3724283
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 04/27/2021
• 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: 07/29/2025
• Device Model Number: 400SMTXSFT0306
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F99245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• 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: 06/11/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Date Report Sent to FDA: 01/01/2005