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

Catalog Number SCH1

Device Problems Mechanical Problem (1384); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

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.This report is associated with mfr report number: 3005168196-2017-02302.The device is not available for return.

Event Description

The patient was undergoing a coil embolization procedure in the left internal carotid (ica) artery using penumbra smart coils (smart coils) and penumbra smart coil detachment handle (handle).During the procedure, the physician placed two smart coils in the target vessel using a non-penumbra microcatheter.The physician then advanced a new smart coil in the aneurysm and attempted to detach it using a handle; however, a dull sound was heard when pulling on the lever of the handle and the smart coil was not detached.The physician then made several attempts to detach the smart coil; however, the coil would not detach.Therefore, the physician decided to retract the handle from the smart coil pusher assembly; however, the handle remained stuck to the smart coil pusher assembly.Thus, the physician forcefully pulled the handle then noticed that the smart coil was pulled out of the aneurysm approximately two centimeters.Therefore, the physician re-advanced the smart coil into the aneurysm and manually pulled the pull wire to detach the smart coil in the aneurysm.While attempting to advance a new smart coil through the microcatheter, the smart coil became entrapped half way through the microcatheter.Therefore, the microcatheter containing the smart coil was removed from the patient¿s body.The physician was then unable to flush microcatheter.It was reported that something was stuck inside the microcatheter and that the guidewire would not advance pass the same position in the microcatheter.Therefore, the procedure was completed using the same smart coil, the same handle and a new microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• 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: 7154978
• MDR Text Key: 96066442
• Report Number: 3005168196-2017-02303
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2017

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: SCH1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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