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

Model Number	RBY2C0435-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
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 gastrointestinal (gi) bleed using ruby coils and a non-penumbra microcatheter.During the procedure, the hospital technologist experienced resistance after advancing approximately a third of a ruby coil into the microcatheter.Subsequently, the physician retracted the introducer sheath slightly and the ruby coil started to take shape in the rotating hemostasis valve (rhv).The physician then decided to re-sheath the ruby coil; however, the coil detached from its pusher assembly outside the patient.The procedure was completed using additional ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2020-02167.Results: the pet lock was intact on the proximal end of the pusher assembly.The stretch resistant wire (sr wire) was fractured, and the proximal constraint sphere was inside the distal detachment tip (ddt).The embolization coil was detached from its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned ruby coil confirmed that the coil was detached from its pusher assembly and revealed a fractured sr wire.If the ruby coil is forcefully retracted against resistance, damage such as a sr wire fracture may occur.Further evaluation of the returned ruby coil revealed offset coil winds on the embolization coil.This damage may have contributed to resistance during procedure and the during re-sheathing of the ruby coil.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10943070
• Report Number: 3005168196-2020-02167
• Device Sequence Number: 16748944
• Product Code: HCG
• UDI-Device Identifier: 00814548012889
• UDI-Public: 00814548012889
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 11/04/2020
• 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: 08/15/2024
• Device Model Number: RBY2C0435-A
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F71153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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