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

Catalog Number RBY2C1035

Device Problems Bent (1059); Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2017

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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital discarded the device.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully placed multiple ruby coils and pod coils using a lantern delivery microcatheter (lantern).The physician then was going to switch to a shorter lantern and therefore advanced a ruby coil through the new lantern on the back table to practice using the new lantern.While advancing, the ruby coil unintentionally detached within the lantern and therefore, the lantern was discarded with the detached ruby coil inside; there was no noted damage to the lantern.It was reported that the pusher wire of the ruby coil had become bent upon removal from the packaging hoop, but was not noticed.The procedure was then completed using a new lantern and additional ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: RUBY 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: 6960245
• MDR Text Key: 90652197
• Report Number: 3005168196-2017-01784
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• 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: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/20/2023
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F67050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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