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

Model Number	400SMTSTD0830
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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 internal iliac artery (iia) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician implanted three smart coils in the inferior mesenteric artery (ima) and two smart coils in the iia.It was reported that the microcatheter had been flushed thoroughly; however, the physician encountered resistance while advancing the next smart coil through the middle of the microcatheter.Therefore, the smart coil was removed, the microcatheter was flushed again, and the smart coil was re-advanced.However, the same issue occurred.The smart coil was therefore removed from the procedure.The procedure was completed using seven additional smart coils 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 offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the smart coil was advanced through its introducer sheath and a demonstration microcatheter without an issue.The root cause of resistance during the procedure could not be determined.Further evaluation revealed pusher assembly bends.This damage was likely incidental to the reported complaint.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.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: 11366282
• Report Number: 3005168196-2021-00331
• Device Sequence Number: 883542
• Product Code: HCG
• UDI-Device Identifier: 00814548014524
• UDI-Public: 00814548014524
• 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
• Report Date (Section B): 01/28/2021
• 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: 06/05/2021
• Device Model Number: 400SMTSTD0830
• Device Catalogue Number: 400SMTSTD0830
• Device Lot Number: F69961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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