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

Catalog Number RBY2C1240

Device Problems Kinked (1339); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2018

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 numbers: 3005168196-2018-00533, 3005168196-2018-00535, 3005168196-2018-00536.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the right and left subclavian arteries using ruby coils.During the procedure, after advancing a ruby coil, the physician retracted it from the right subclavian artery because the ruby coil was the wrong size.However, upon removal from the lantern delivery microcatheter (lantern), the ruby coil became kinked.This same issue then occurred with a second ruby coil.The physician then attempted to place a ruby coil in the left subclavian artery, however the pusher assembly of the ruby coil became kinked upon insertion into a lantern; therefore, it was removed.This same issue then occurred with another ruby coil, and the ruby coil was removed.The procedure was then completed using 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: 7329085
• MDR Text Key: 102117175
• Report Number: 3005168196-2018-00534
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/26/2023
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F66214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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
• Patient Age: 46 YR