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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
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.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern).A ruby coil then unintentionally detached within the lantern as the lantern backed in to the non-penumbra sheath.The physician attempted to remove the lantern with the ruby coil inside, however the ruby coil remained in the sheath; therefore, the physician pulled out the ruby coil using his fingers.As the ruby coil was being pulled out, the coil broke into two pieces.The physician removed one piece, and the second piece flowed into the target location; therefore, it was left in place.The procedure ended at this point.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: 6855587
• Report Number: 3005168196-2017-01531
• Device Sequence Number: 801158
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2017

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: No Information
• Device Expiration Date: 03/29/2024
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F68732
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR