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

Model Number	400SMTHXSFT0204
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil could not confirm the reported complaint due to the device damage.Evaluation revealed that the embolization coil had offset coil winds along its length.This damage was likely a result of forceful advancement the device against resistance outside the introducer sheath.The root cause of the resistance could not be determined.Further evaluation of the device revealed kinks in the pusher assembly, the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock and blood was inside the introducer sheath.These damages were likely incidental to the complaint.The smart coil was unable to be advanced from its returned position due to the offset coil winds.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using penumbra smart coils (smart coil), a penumbra smart coil detachment handle (handle), a non-penumbra microcatheter, and non-penumbra coils.It was noted that the patient¿s anatomy was moderately tortuous and mildly narrowed.During the procedure, the physician successfully implanted two non-penumbra coils in the target vessel.While attempting to advance a smart coil to the target vessel, the smart coil would not advance at all past its initial position within its introducer sheath.Therefore, the smart coil was removed.It was reported that the physician also attempted to advance the smart coil within its introducer sheath on the back table; however, it was unsuccessful.The procedure was completed using two non-penumbra coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 1.Section e.Box 1.Title 2.Section e.Box 3.Occupation 3.Section h.Box 6.Results code 1,2 & 3 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: 12628551
• Report Number: 3005168196-2021-02284
• Device Sequence Number: 1442981
• Product Code: HCG
• UDI-Device Identifier: 00814548015712
• UDI-Public: 00814548015712
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022
• 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: 01/06/2025
• Device Model Number: 400SMTHXSFT0204
• Device Catalogue Number: 400SMTHXSFT0204
• Device Lot Number: F95397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005