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

Catalog Number	400SMTHXSFT0304
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The device was implanted into the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra smart coils.During the procedure, the physician successfully deployed and detached multiple smart coils using a non-penumbra microcatheter.While attempting to implant the last smart coil, it was reported that the smart coil felt sticky within the non-penumbra microcatheter, and consequently, the smart coil remained partially within the tip of the microcatheter, causing a small 1 cm coil tail prolapse into the parent vessel when the smart coil was detached.Additionally, the smart coil pusher assembly fractured and was stuck within the rotating hemostasis valve(rhv) as the physician retracted the pusher wire after placing the smart coil.The procedure ended at this point and the pusher wire was removed as the physician removed the microcatheter.The physician administered an unknown medication and placed the patient on aspirin.It was adjudicated that the coil tail prolapse was a non-serious device-related adverse event that was unrelated to the disease state, and had a probable relationship to both the procedure and the smart coil system.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7155134
• Report Number: 3005168196-2017-02317
• Device Sequence Number: 13925228
• Product Code: HCG
• UDI-Device Identifier: 00814548015774
• UDI-Public: 00814548015774
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/12/2022
• Device Catalogue Number: 400SMTHXSFT0304
• Device Lot Number: F73809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 46 YR