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

Catalog Number	RBY4C0630
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
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: 3005168196-2019-02392.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the sinus sagittalis using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully placed penumbra coils in the target vessel using the lantern.The physician then advanced a ruby coil to the vessel but then decided to reposition the ruby coil.While retracting the ruby coil to reposition it, the physician experienced resistance, and the ruby coil unintentionally detached in the vessel; subsequently, the physician attempted to remove it using a snare device, but the ruby coil stretched and remained in the vessel.The procedure was completed using another ruby coil, another lantern, and glue.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: 9507689
• Report Number: 3005168196-2019-02391
• Device Sequence Number: 19158665
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 12/11/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2025
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F78451
• 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: 12/11/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Date Report Sent to FDA: 01/01/2005