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

Model Number	RBY2C2060-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
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 in the internal iliac artery (iia) using ruby coils and a non-penumbra microcatheter.During the procedure, the physician attempted to advance a ruby coil through the microcatheter and encountered resistance.Subsequently, the ruby coil pusher wire became kinked.Therefore, the ruby coil was removed.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 section was inadvertently missed on the follow-up #01 and is being included on this follow-up #02: 3005168196-2019-02311.Box 10./11.Narrative/corrected data during functional testing, the embolization coil was able to advance from its introducer sheath without issue; however, the coil detached once outside of the sheath due to the fractured pusher assembly.No additional function testing could be performed.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end.The pusher assembly was kinked and fractured approximately 5.0 cm from the proximal end.The pusher assembly was kinked at approximately 59.0 and 72.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned ruby coil revealed offset coil winds and a kinked pusher assembly.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.Forcefully advancing against resistance may also contribute to damage such as a kink.The pusher assembly was kinked and fractured on the proximal end; this damage is likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils are 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: 9454547
• Report Number: 3005168196-2019-02311
• Device Sequence Number: 2114344
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C2060-B
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F90636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 02/21/2020; 02/21/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/01/2020; 03/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005