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

Model Number	400SMTSFT0510
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first returned smart coil could not confirm that the device was unable to be advanced through the introducer sheath.The smart coil was returned with the introducer sheath off the pusher assembly.Due to the returned condition, the root cause of the reported complaint could not be determined.Further evaluation revealed that the pusher assembly was kinked, and the embolization coil had offset coil winds and a knot.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.During the functional test, the knot was removed from the embolization coil.The device was then re-sheathed with resistance due to the kinks in the pusher assembly inside the returned introducer sheath.The smart coil was then advanced out of its introducer sheath without an issue.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 number: 3005168196-2021-01178.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using penumbra smart coils (smart coils).During the procedure, a smart coil would not advance at all within its introducer sheath.Subsequently, the hospital staff kinked the smart coil; therefore, the smart coil was removed.Afterwards, the physician attempted to advance a new smart coil within its introducer sheath; however, the same issue occurred.The smart coil would not advance at all within its introducer sheath; therefore, the smart coil was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11898134
• Report Number: 3005168196-2021-01177
• Device Sequence Number: 1388284
• Product Code: HCG
• UDI-Device Identifier: 00814548015101
• UDI-Public: 00814548015101
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021
• 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: 10/28/2025
• Device Model Number: 400SMTSFT0510
• Device Catalogue Number: 400SMTSFT0510
• Device Lot Number: F101570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Date Report Sent to FDA: 01/01/2005