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

Catalog Number	400SMTHXSFT0410
Medical Device Problem Codes	Bent (1059); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the penumbra smart coil (smart coil) pusher assembly midjoint was stuck under the introducer sheath friction lock and the friction lock was wrinkled.The pusher assembly was kinked along its length including just proximal to the introducer sheath.During functional analysis, the smart coil was initially unable to be advanced.After retracting the coil backwards and resheathing, the coil was able to be advanced out of its sheath and through a demonstration microcatheter encountering some resistance when the pusher assembly kinks entered the microcatheter.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was stuck under the introducer sheath friction lock.The friction lock inner diameter (id) is smaller than the rest of the introducer sheath, which allows the introducer sheath to properly seat on the pusher assembly mid-joint.If the pusher assembly mid-joint is forcefully withdrawn beyond the introducer sheath friction lock, it is likely that resistance will be experienced upon attempting to advance the coil.Further evaluation revealed kinks along the length of the pusher assembly.The kink just proximal to the introducer sheath was likely due to forcefully gripping and advancing the device against strong resistance caused by the mid-joint and friction lock.The remaining kinks were likely incidental 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pcom) using penumbra smart coils (smart coils).During the procedure, while attempting to load a smart coil into a non-penumbra microcatheter through the rotating hemostasis valve (rhv), the physician experienced resistance and the smart coil would not advance out its introducer sheath.It was reported that the smart coil pusher assembly became bent from trying to advance the coil out of its introducer sheath.Therefore, the introducer sheath containing the smart coil was removed.The procedure was then completed using a new smart coil and the same microcatheter.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: 7310424
• Report Number: 3005168196-2018-00473
• Device Sequence Number: 956327
• Product Code: HCG
• UDI-Device Identifier: 00814548015835
• UDI-Public: 00814548015835
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 02/01/2018

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: Physician
• Device Expiration Date: 06/18/2022
• Device Catalogue Number: 400SMTHXSFT0410
• Device Lot Number: F77753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR