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

Catalog Number	RBY2C1857
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The pull wire was retracted out of distal detachment tip (ddt) and the embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned ruby coil revealed that the pusher assembly was fractured.If the device is forcefully handled upon removal from its packaging, damage such as a kink may occur.If the kink is attempted to be straightened, damage such as a fracture may occur.Further evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly.If the fractured segments of the pusher assembly are separated and the pull wire is retracted out of the ddt, the embolization coil will detach from its pusher assembly.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.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 medical procedure, the hospital staff noticed the black alignment zone (pet lock) of the ruby coil was bent upon removal from the packaging.The damage to the ruby coil was found prior to use; therefore, the coil was not used in the procedure.The procedure was completed using 32 more ruby coils.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7961813
• Report Number: 3005168196-2018-02027
• Device Sequence Number: 19146238
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 09/13/2018
• Report Date (Section F): 01/01/2005

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: 02/20/2026
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F82021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005