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

Model Number	RBY2C2457-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-02103.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat type ii endoleak using ruby coils, a lantern delivery microcatheter (lantern), and a non-penumbra catheter.During the procedure, while inserting a ruby coil into the lantern, the pusher assembly of the ruby coil kinked.Therefore, the ruby coil was removed.Next, while advancing a new ruby coil through the distal end of the lantern, the pusher assembly of the ruby coil kinked.Subsequently, the physician retracted the ruby coil back into the distal tip of the lantern and then removed the lantern with the ruby coil together from the patient.Afterwards, the ruby coil was removed from the lantern.The procedure was completed using five additional ruby coils, the same lantern, and the same catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was kinked in multiple locations.The pusher assembly was fractured approximately 67.5 cm from the proximal end.The distal fractured portion of the pusher assembly was not returned.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the first returned ruby coil pusher assembly confirmed that the pusher assembly was kinked and revealed a fracture.If the ruby coil is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may result in a fracture.Further evaluation of the returned ruby coil revealed that the embolization coil was detached.This damage was likely incidental to the reported complaint.Evaluation of the second returned ruby coil pusher assembly confirmed that the pusher assembly was kinked and revealed a fracture.If the ruby coil is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device may result in a fracture.Further evaluation of the returned ruby coil revealed that the embolization coil was detached.This damage was likely incidental to the reported complaint.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.This report is associated with mfr report number: 3005168196-2020-02103 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10903755
• Report Number: 3005168196-2020-02104
• Device Sequence Number: 2709262
• Product Code: HCG
• UDI-Device Identifier: 00814548019291
• UDI-Public: 00814548019291
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 10/27/2020
• 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 Model Number: RBY2C2457-B
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F96149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005