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

Model Number	RBY2C1035-B
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2020-00706.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left hypogastric artery using a ruby coil, ruby coil detachment handles (handle) and pod coils.During the procedure, the physician advanced a ruby coil into the target vessel and used a handle to detach it; however, the ruby coil failed to detach after multiple attempts.Therefore, the ruby coil was removed.Next, while removing a pod coil from the packaging hoop, the hospital technician noticed the pusher assembly of the pod coil was bent; therefore, the pod coil was not used in the procedure.The physician then advanced a new pod coil into the target vessel and used the same handle to detach it; however, the pod coil failed to detach.Therefore, the physician removed the handle.The procedure was completed using a new handle to detach the same pod coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10116517
• Report Number: 3005168196-2020-00707
• Device Sequence Number: 13915249
• Product Code: HCG
• UDI-Device Identifier: 00814548019062
• UDI-Public: 00814548019062
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2026
• Device Model Number: RBY2C1035-B
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F83878
• Was Device Available for Evaluation?: No
• 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: 05/14/2020
• Initial Report FDA Received Date: 06/03/2020
• 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