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

Model Number	400SMTXSFT0208
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 iliolumbar artery using penumbra smart coils (smart coils), non-penumbra coils, and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician implanted one other coil into the target location.Next, the physician encountered resistance when a smart coil was advanced approximately six to seven centimeters into the target vessel.It was reported under fluoroscopy that the smart coil was snaked inside the microcatheter.Therefore the smart coil was removed.Upon removal, it was noted that the smart coil was kinked approximately 1 cm away from the proximal end of the coil.The procedure was completed by implanting three other coils with the same microcatheter, as well as implanting four other coils through a parent catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 27.0, 28.0, 146.0 and 149.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.The introducer sheath was not returned for evaluation.Conclusions: evaluation of the returned smart coil revealed offset coil winds on its embolization coil and kinks on the pusher assembly.If the device is forcefully advanced against resistance, damage such as this may occur.Due to the offset coil winds, the device was unable to be functionally tested; therefore, the root cause of the resistance could not be determined.Further evaluation of the device revealed additional pusher assembly kinks.These kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11088885
• Report Number: 3005168196-2020-02371
• Device Sequence Number: 3785871
• Product Code: HCG
• UDI-Device Identifier: 00814548015552
• UDI-Public: 00814548015552
• 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,Followup
• Report Date (Section B): 11/30/2020
• 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: 04/09/2024
• Device Model Number: 400SMTXSFT0208
• Device Catalogue Number: 400SMTXSFT0208
• Device Lot Number: F89525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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