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

Model Number	RBY4C0204-B
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); 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	11/23/2020
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 physician was undergoing a coil embolization procedure in the splenic artery using ruby coils and non-penumbra microcatheter.During the procedure, while advancing the ruby coil through the microcatheter, the physician experienced resistance and the ruby coil would not advance beyond approximately the last two centimeters of the microcatheter.Consequently, the pusher assembly of the ruby coil became kinked and, therefore, it was removed.The procedure was completed using another coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2020-02290 1.Section d.Box 10.Device available for evaluation? (do not send to fda).2.Section h.Box 3.Reason for non-evaluation.3.Section h.Box 6.Method code 1, method code 2 & method code 3.4.Section h.Box 6.Results code 1.5.Section h.Box 6.Conclusions code 1.6.Section h.Box 10./11.Narrative/corrected data.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.H3 other text : placeholder.
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 #02 mfr report:3005168196-2020-02290 1.Section g.Box 5.510(k).Please note that the device in complaint was not expected to be returned; however, on 9-apr-2021 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) 2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1, method code 2, and method code 3.5.Section h.Box 6: results code 1.6.Section h.Box 6.Conclusions code 1.Additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy).Evaluation of the returned ruby coil confirmed kinks near the proximal end of its pusher assembly.If the device is forcefully advanced against resistance, damage such as this may occur.Further evaluation revealed a pusher assembly fracture.This damage was likely incidental to the complaint and may have occurred during packaging for return for penumbra.Due to the fracture the ruby coil was unable to be advanced through a demonstration lantern during functional testing.The root cause of the reported resistance experienced during the procedure could not be determined.Further evaluation of the device also revealed that the pet lock was separated on the proximal end of the pusher assembly.This damage was likely incidental to the complaint.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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11031493
• Report Number: 3005168196-2020-02290
• Device Sequence Number: 668537
• Product Code: HCG
• UDI-Device Identifier: 00814548018270
• UDI-Public: 00814548018270
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 06/24/2021
• 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: RBY4C0204-B
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F88047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• 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: 01/14/2005; 05/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/24/2021; 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Date Report Sent to FDA: 01/01/2005