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

Catalog Number SCH1

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2017-02276.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure in the anterior communicating artery (acomm) using a penumbra smart coil (smart coil) and a penumbra smart coil detachment handle (handle).During the procedure, the physician advanced a smart coil into the target vessel using a non-penumbra microcatheter and attempted to detach it using the handle.It was reported that the pet lock was separated and it looked like the coil was detached; however, while attempting to retract the coil pusher assembly, the smart coil began to pull back in the microcatheter and was not detached.The physician then attempted to push the smart coil back forward but the smart coil would not advance.It was reported that there was initially a little space between the coil pusher wire and the embolization coil under fluoroscopy as they were both being pulled back together.That space began to increase in distance, and eventually the ¿string¿ gave free and the pusher wire pulled back alone.Therefore, the physician used a snare device to remove the detached coil and the procedure was completed using additional coils.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: 7148481
• MDR Text Key: 96124802
• Report Number: 3005168196-2017-02277
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• 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: 11/27/2017

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
• Device Operator: Physician
• Device Expiration Date: 07/26/2022
• Device Catalogue Number: SCH1
• Device Lot Number: F78390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR