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

Catalog Number	400SMTHXSFT1H02
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (aca) using penumbra smart coils (smart coils), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, a non-penumbra sheath, and a guidewire.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted two non-penumbra coils and one smart coil using the handle.After advancing the next smart coil into the target location, the physician used the handle to detach the smart coil; however, the coil did not detach.While removing the smart coil, the distal end of the coil was in the middle of the microcatheter when it unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached smart coil was removed from the patient and the smart coil was flushed out of the microcatheter on the back table.The handle was no longer required and was removed.The procedure was completed using a non-penumbra coil, the same microcatheter, the same sheath, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, and the pull wire was retracted out of the ddt.This indicates a successful detachment attempt, and the embolization coil was detached as intended.Therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed that the pusher assembly was kinked throughout its length and the embolization coil had offset coil winds throughout its length.This damage was likely incidental to the complaint.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.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the initial mfr report and are being included on this follow-up #01 mfr report:3005168196-2022-00376.1.Section h.Box 6.Results code.2.Section h.Box 6.Conclusions code.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2022-00376.1.Section h.Box 10./11.Narrative/corrected data.The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 15217695
• Report Number: 3005168196-2022-00376
• Device Sequence Number: 15119305
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 814548015651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2022
• 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: 07/26/2026
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F107979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• 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: 01/14/2005
• Supplement Date Received by Manufacturer: 01/14/2005; 08/15/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 08/12/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005