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

Model Number	400SMTHXSFT1H02
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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 in the anterior communicating artery (acom) using a penumbra smart coil (smart coil).During the procedure, a smart coil would not advance within its introducer sheath after the physician made several attempts.Subsequently, the physician kinked the pusher assembly of the smart coil; therefore, the smart coil was removed.The procedure was completed using other smart coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned smart coil confirmed a kink in the pusher assembly near the mid-joint.Further evaluation of the device revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced during advancement and the device may not be advanced out of the introducer sheath.This resistance likely contributed to the kink in the pusher assembly near the mid-joint.During functional testing, the smart coil was unable to be advanced from its returned position due to the pusher assembly kink.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 "study" was selected in section g3 for report source; however, additional information received on 13-sep-2023 indicated that this was not from a clinical study.

• 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: 12072418
• Report Number: 3005168196-2021-01419
• Device Sequence Number: 4765091
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023
• 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: 07/13/2025
• Device Model Number: 400SMTHXSFT1H02
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F98885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 01/14/2005
• Initial Report FDA Received Date: 06/26/2021
• Supplement Report FDA Received Date: 08/31/2021; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2020
• 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 Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005