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

Catalog Number	RBY2C0520
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned device was fractured approximately 77.0 cm from the proximal end.The pusher assembly was kinked approximately 5.0 cm from the proximal end.Several bends were present along the pusher assembly.The proximal part of the pusher assembly and pet lock were missing.The pusher assembly was approximately 169.0 cm in length, missing the proximal end fractured portion of the device.Conclusions: evaluation of the returned ruby coil revealed a fractured device.The reported complaint mentioned the ruby coil was bent while still in its packaging hoop.If the device was forcefully mishandled during removal from the packaging hoop, the pusher assembly may become damaged.If a damaged pusher assembly is further mishandled the damage may worsen to a fracture.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, a hospital staff found that the pusher wire of a ruby coil was bent prior to removing the coil from the packaging hoop.The damage to the ruby coil was found prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed using additional 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: 8099959
• Report Number: 3005168196-2018-02306
• Device Sequence Number: 16624611
• Product Code: HCG
• UDI-Device Identifier: 00814548018638
• UDI-Public: 00814548018638
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 10/24/2018
• 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: 06/11/2026
• Device Catalogue Number: RBY2C0520
• Device Lot Number: F84024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• 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: 10/24/2018
• Initial Report FDA Received Date: 11/23/2018
• 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