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

Catalog Number RBY4C0620

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2018

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.This report is associated with mfr report number: 3005168196-2018-00527.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure to treat a collateral vessel off a dialysis fistula using ruby coils.During the procedure, while advancing a ruby coil into the target vessel using a lantern delivery microcatheter (lantern), the ruby coil became stuck in the lantern with approximately 10 centimeters of coil outside of the lantern; therefore, the physician decided to retract the ruby coil back into the lantern.However, upon retraction, the ruby coil unintentionally detached, with approximately 10 centimeters of the coil in target vessel and 10 centimeters of the coil in lantern.The physician considered injecting the coil but was concerned due to the high flow of the fistula that the coil would migrate centrally.Therefore, the physician slowly pulled back the lantern into the glide catheter and removed the entire system from the patient.The procedure was completed using other 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: 7325933
• MDR Text Key: 101989654
• Report Number: 3005168196-2018-00526
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F71559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• 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