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

Model Number	400SMTXSFT0306
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
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 number: 3005168196-2021-01528.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, a smart coil became stuck at the hub of the microcatheter and would not advance further.Therefore, the smart coil was removed.The physician then attempted to advance a second smart coil; however, the same issue occurred.Therefore, the smart coil was also removed.The procedure was completed using new smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil could not confirm the reported complaint.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.This damage was incidental to the reported complaint and the root cause could not be determined.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, and no further issues occurred after the pusher assembly mid-joint out of the friction lock.The smart coil was advanced through a demonstration microcatheter without an issue.Evaluation of the second returned smart coil could not confirm the reported complaint.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock, and the pusher assembly was kinked near the mid-joint.This damage was incidental to the reported complaint and the root cause could not be determined.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance, and additional resistance due to the kink in the pusher assembly near the mid-joint.The smart coil was unable to be advanced through a demonstration microcatheter due to the kink in the pusher assembly.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: 3005168196-2021-01528.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: 12164713
• Report Number: 3005168196-2021-01527
• Device Sequence Number: 14502832
• Product Code: HCG
• UDI-Device Identifier: 00814548015354
• UDI-Public: 00814548015354
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 10/06/2021
• 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: 03/16/2025
• Device Model Number: 400SMTXSFT0306
• Device Catalogue Number: 400SMTXSFT0306
• Device Lot Number: F96995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005