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

Catalog Number	400SMTHXSFT0203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
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.This report is associated with mfr report number: 3005168196-2019-02151.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a subarachnoid hemorrhage (sah) using penumbra smart coils (smart coils).During the procedure, the physician successfully placed one smart coil in the target vessel using a non-penumbra microcatheter.The physician then advanced the second smart coil to the target vessel and detached it from the pusher assembly; subsequently, the pusher assembly was removed.Next, while advancing a third smart coil into the microcatheter, the physician experienced resistance at the beginning but continued to advance the smart coil until it reached the distal tip of the microcatheter, where it became stuck; therefore, the microcatheter containing the smart coil was removed.After removal, the physician checked the microcatheter and noticed that a fragment of the second smart coil pusher assembly was inside the microcatheter; subsequently, the fragment was flushed out.It was reported that the pusher assembly of the second smart coil was stuck in the rotating hemostasis valve (rhv) and fractured inside the rhv while being removed.The procedure was completed using two other smart coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned fractured pusher assembly has approximately 3.0 cm in length.Conclusions: evaluation of the returned pusher assembly confirmed a fracture.If the pusher assembly is forcefully retracted against resistance, damage such as a fracture may occur.The reported complaint indicated that the pusher assembly was stuck inside the rhv and fractured while retracting.The rhv used in the procedure was not returned for evaluation; therefore, the root cause of the pusher assembly stuck inside the rhv was unable to be determined.Evaluation of the second smart coil revealed a functional device.During functional testing, the returned smart coil was able to be advanced through a demonstration introducer sheath and a demonstration microcatheter without issue.Further evaluation of the device revealed that the embolization coil had offset coil winds.These offset coil winds were likely occurred during advancement against the resistance.The complaint indicated that the resistance was encountered, and the smart coil was unable to be advanced through the non-penumbra microcatheter due to the fragment from the fractured pusher assembly of the first smart coil was inside the non-penumbra microcatheter.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.This report is associated with mfr report number: 3005168196-2019-02151.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9342152
• Report Number: 3005168196-2019-02150
• Device Sequence Number: 2157107
• Product Code: HCG
• UDI-Device Identifier: 00814548015705
• UDI-Public: 00814548015705
• 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): 10/24/2019
• 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: 08/10/2022
• Device Catalogue Number: 400SMTHXSFT0203
• Device Lot Number: F78671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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