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

Catalog Number	RBY2C1240
Medical Device Problem Codes	Kinked (1339); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7329085
• Report Number: 3005168196-2018-00534
• Device Sequence Number: 11191593
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

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
• Operator of Device: Physician
• Device Expiration Date: 10/26/2023
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F66214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR