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

Catalog Number	RBY4C1240-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2016
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 number: 3005168196-2016-01282.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to deploy a ruby coil in the target vessel using a lantern delivery microcatheter , the physician noticed the ruby coil was too big for the aneurysm, therefore it was removed.However, while resheathing the ruby coil outside of the patient's body, the technologist experienced resistance and the ruby coil unintentionally detached from the pusher assembly.The physician then attempted to deploy a different size ruby coil in the aneurysm; however, the ruby coil was too big for the aneurysm and it was removed.Upon attempting to resheath this ruby coil, the technologist experienced resistance again and the ruby coil unintentionally detached as well.The procedure was then completed using new ruby coils and the same lantern delivery microcatheter.The physician did not use a rotating hemostasis valve (rhv), however, the microcatheter was flushed after every coil.There was no adverse effect on 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: 5932789
• Report Number: 3005168196-2016-01281
• Device Sequence Number: 10921145
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2016

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: Health Professional
• Device Expiration Date: 05/21/2024
• Device Catalogue Number: RBY4C1240-A
• Device Lot Number: F69416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2016
• Initial Report FDA Received Date: 09/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR