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

Model Number	RBY4C0860-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned pod8 revealed an undamaged and a functional device.During functional testing, the pod8 was able to advance through a demonstration lantern without issue.The reported complaint could not be confirmed.Further evaluation of the device revealed kinks along the length of the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Evaluation of the returned ruby coil revealed an undamaged and a functional device.During functional testing, the ruby coil was able to advance through a demonstration lantern without issue.The reported complaint could not be confirmed.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.This report is associated with mfr report number: 3005168196-2021-00600.
Event or Problem Description
The patient was undergoing a coil embolization procedure right renal artery using a ruby coil, a pod coil, and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance after advancing a ruby coil approximately halfway into the lantern.Therefore, the ruby coil was removed.The physician then attempted to advance a pod coil through the lantern; however, the same issue occurred.Therefore, it was removed.The procedure was completed using new ruby coils and the same lantern.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: 11578743
• Report Number: 3005168196-2021-00601
• Device Sequence Number: 17009456
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/26/2021
• 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: RBY4C0860-B
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F101716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• 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: 02/26/2021
• Initial Report FDA Received Date: 03/27/2021
• 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