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

Catalog Number	RBY4C0406-A
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked approximately 2.0 cm from the proximal end; the pull wire was retracted on the proximal end of the pusher assembly.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned device revealed that the pusher assembly was kinked on the proximal end.This type of damage likely occurred during removal of the device from the packaging hoop.Further evaluation revealed that the pet lock was broken and the pull wire was retracted.A broken pet lock typically indicates an attempt was made to detach the embolization coil from its pusher assembly.If the pull wire is retracted with force, by design the pet lock will break and the embolization coil should detach from the pusher assembly.It is likely that the pet lock was broken and the pull wire was retracted during removal of the device from its packaging hoop.Ruby coils are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a coil embolization procedure, the back end of a ruby coil pusher assembly was found to be kinked while in the delivery hoop.The kinked pusher assembly was found prior to use and therefore, the ruby coil was not used for the procedure.The procedure was completed using a new ruby coil.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5773397
• Report Number: 3005168196-2016-00946
• Device Sequence Number: 225397
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2016

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: 12/09/2023
• Device Catalogue Number: RBY4C0406-A
• Device Lot Number: F66893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2016
• Initial Report FDA Received Date: 07/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1