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

Model Number	400SMTXSFT3H08
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds on the embolization coil.This indicates that the device was likely advanced from its starting position in the introducer sheath.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, resistance may be experienced during advancement and damage such as offset coil winds may occur.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock and kinks in the pusher assembly.This damage was likely incidental to the reported complaint and may have occurred after removal from the procedure.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath from the returned position, and the pusher assembly could not be advanced at all.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 splenic artery using penumbra smart coils (smart coils), non-penumbra microcatheters, and a non-penumbra parent catheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician implanted six smart coils and three non-penumbra coils into the target location.After aligning the next smart coil introducer sheath inside the hub of the microcatheter, the physician attempted to advance the smart coil; however, the smart coil would not advance past its initial position within its introducer sheath.Therefore, it was removed.The procedure was completed using another smart coil, two other coils and the same microcatheters.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: 11617471
• Report Number: 3005168196-2021-00690
• Device Sequence Number: 3262754
• Product Code: HCG
• UDI-Device Identifier: 00814548017129
• UDI-Public: 00814548017129
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021
• 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: 05/18/2021
• Device Model Number: 400SMTXSFT3H08
• Device Catalogue Number: 400SMTXSFT3H08
• Device Lot Number: F69386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• 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: 03/09/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005