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

Model Number	400SMTHXSFT0103
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	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned smart coil revealed offset coil winds.If the introducer sheath is not aligned properly within the hub of a parent microcatheter, the embolization coil may begin to take shape within the hub and resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the offset coil winds.During functional testing, the smart coil was advanced out of its introducer sheath with resistance due to the offset coil wind.Resistance was experienced while attempting to advance the smart coil through the hub of a demonstration microcatheter due to the offset coil winds, and the smart coil could not advance any further.Penumbra coils are 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 anterior communicating artery (aca) using a penumbra smart coil (smart coil) and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted five non-penumbra coils in the target vessel using the microcatheter.While attempting to advance the smart coil into the microcatheter, it became stuck in the hub of the microcatheter.Therefore, the smart coil was removed.The physician performed an angiogram and noticed that the aneurysm was sufficiently packed; therefore, no additional coils were required and the procedure was successfully completed.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: 11662634
• Report Number: 3005168196-2021-00745
• Device Sequence Number: 11517132
• Product Code: HCG
• UDI-Device Identifier: 00814548015620
• UDI-Public: 00814548015620
• 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): 03/17/2021
• 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: 04/09/2022
• Device Model Number: 400SMTHXSFT0103
• Device Catalogue Number: 400SMTHXSFT0103
• Device Lot Number: F75513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• 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: 03/17/2021
• Initial Report FDA Received Date: 04/14/2021
• 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