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

Model Number	RBY4C1240-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (pavm) using ruby coils, and a velocity delivery microcatheter (velocity).During the procedure, the physician was unable to advance a ruby coil past the proximal end of the velocity, and experienced resistance.Therefore, the ruby coil was removed.The procedure was completed using a new ruby coil, pod coil, and the same velocity.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Section g.Box 3.Report source.Evaluation of the returned ruby coil revealed offset coil winds throughout the embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.These offset coil winds likely contributed to the resistance while advancing the device through the hub of the microcatheter during the procedure and functional testing.During functional testing, the ruby coil was unable to advance through a demonstration velocity or the returned velocity due to the offset coil winds.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11042036
• Report Number: 3005168196-2020-02305
• Device Sequence Number: 19159401
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 11/23/2020
• 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 Expiration Date: 09/19/2026
• Device Model Number: RBY4C1240-A
• Device Catalogue Number: RBY4C1240
• Device Lot Number: F86007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Date Report Sent to FDA: 01/01/2005