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

Model Number	400SMTSFT3H06
Medical Device Problem Code	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	11/09/2020
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 basilar artery using a penumbra smart coil (smart coil), non-penumbra coils, and two non-penumbra microcatheters.During the procedure, the physician placed three non-penumbra coils into the target vessel using a microcatheter.Then, the physician placed successfully a smart coil into the target vessel using a microcatheter.Afterwards, the physician experienced resistance while retracting the pusher assembly of the smart coil through the microcatheter.Subsequently, the physician felt as if the smart coil unraveled; however, no damage to the smart coil was noted via fluoroscopy.The procedure was completed using another coil and the same microcatheter.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Results: the pet lock was separated on the proximal end of the pusher assembly.The pusher assembly had kinks and bends along its length.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned smart coil pusher assembly revealed kinks and bends along its length.This damage was likely incidental to the complaint and may have occurred during packaging for the device returned.Due to the returned damage, the outer diameter (od) of the pusher assembly was unable to be measured and functional testing could not be continued.The root cause of the resistance experienced while retracting the pusher assembly from the microcatheter during the procedure could not be determined.Further evaluation of the device revealed that the pet lock was separated.This damage likely occurred while detaching the smart coil during the procedure.Based on the reported complaint, the embolization coil was implanted without issue.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10955131
• Report Number: 3005168196-2020-02200
• Device Sequence Number: 2177746
• Product Code: HCG
• UDI-Device Identifier: 00814548017006
• UDI-Public: 00814548017006
• 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): 11/10/2020
• 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: 01/08/2020
• Device Model Number: 400SMTSFT3H06
• Device Catalogue Number: 400SMTSFT3H06
• Device Lot Number: F73570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005