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

Model Number	RBY2C0435-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01196.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, two ruby coils unintentionally detached.It is unknown how the procedure was completed.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Please note the following section is being updated on this follow-up # 01 mfr report:3005168196-2020-01197.1.Section b.Box 5.Describe event or problem evaluation of the first returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Further evaluation of the returned ruby coil revealed that the sr wire was fractured, and the pusher assembly was kinked.If the ruby coil is forcefully retracted against resistance, damage such as a sr wire fracture may occur.The kink in the pusher assembly was likely incidental to the reported complaint.Evaluation of the second returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Further evaluation of the returned ruby coil revealed that the sr wire was fractured.If the ruby coil is forcefully retracted against resistance, damage such as a sr wire fracture may occur.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: 1.3005168196-2020-01196,.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil unintentionally detached while being retracted.It was also reported that the same issue occurred with another ruby coil.It is unknown how the procedure was completed.There was no report of an adverse effect to this patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10405278
• Report Number: 3005168196-2020-01197
• Device Sequence Number: 16891976
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020
• 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: RBY2C0435-A
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F93105
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 03/12/2021
• 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