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

Model Number	400SMTHXSFT0308
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
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.This report is associated with mfr report number: 3005168196-2020-00354.
Event or Problem Description
The patient was undergoing a coil embolization procedure for a vessel sacrifice in the left vertebral artery using penumbra smart coils (smart coils) and non-penumbra microcatheter.During the procedure, the physician placed multiple smart coils in the target vessel using the microcatheter.The physician then attempted to advance another smart coil; however, the coil would not advance at all within its introducer sheath.Therefore, the smart coil was removed.The physician attempted to advance a new smart coil, however, the same issue occurred, and the coil would not advance within its introducer sheath; therefore, the smart coil was removed.The procedure was completed using new smart coils.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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted into the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forceful advancement of the device against this resistance may have contributed to the kinks observed near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was advanced through the introducer sheath friction lock with resistance.The smart coil was then able to advance through its introducer sheath with resistance due to the kinks on the pusher assembly.The device was unable to be advanced through a demonstration microcatheter due to the pusher assembly kink.Evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.During functional testing, the smart coil was unable to advance within its introducer sheath from its returned position within the introducer sheath; therefore, the introducer sheath was removed distally, and the smart coil was re-sheathed properly.The smart coil was then able to advance through its introducer sheath and a demonstration microcatheter without issue.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.This report is associated with mfr report number: 3005168196-2020-00354.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9831178
• Report Number: 3005168196-2020-00355
• Device Sequence Number: 740379
• Product Code: HCG
• UDI-Device Identifier: 00814548015798
• UDI-Public: 00814548015798
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020
• 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: 03/13/2024
• Device Model Number: 400SMTHXSFT0308
• Device Catalogue Number: 400SMTHXSFT0308
• Device Lot Number: F89077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 90
• Date Report Sent to FDA: 01/01/2005