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

Catalog Number 400SMTHXSFT0304

Device Problems Fracture (1260); Mechanical Problem (1384); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  Injury  

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 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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7155134
• MDR Text Key: 96061679
• Report Number: 3005168196-2017-02317
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015774
• UDI-Public: 00814548015774
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/12/2022
• Device Catalogue Number: 400SMTHXSFT0304
• Device Lot Number: F73809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR