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

Catalog Number RBY4C0860

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

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.This report is associated with mfr report numbers: 3005168196-2017-02320, 3005168196-2017-02321, 3005168196-2017-02323, 3005168196-2017-02324.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, while advancing a ruby coil through the lantern, the physician experienced resistance and the ruby coil was unable to advance any further.Upon attempting to retract the ruby coil, the physician experienced resistance again and the ruby coil unintentionally detached within the lantern.Therefore, the physician removed the lantern with the detached ruby coil from the patient and flushed out the ruby coil, before reinserting the lantern.However, this same incident occurred with three additional ruby coils.When the physician removed the lantern with the fourth detached ruby coil, a kink was found on the lantern.The procedure was therefore completed using a px slim delivery microcatheter (px slim) and a new ruby coil.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: 7148190
• MDR Text Key: 96225475
• Report Number: 3005168196-2017-02322
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F78453
• 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: 08/01/2017
• 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