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

Model Number	RBY2C1460-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 lantern delivery microcatheter (lantern).It should be noted that the patient's anatomy was tortuous, calcified, and narrowed.During the procedure, after flushing the lantern, the physician encountered resistance while advancing a ruby coil through the proximal segment of the lantern.The ruby coil was then re-sheathed.During re-advancement, the physician encountered even stronger resistance in the same location.Therefore, the ruby coil was completely removed and no longer used in the procedure.The procedure was completed using a new ruby coil, two pod packing coils (pod pcs), and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed pusher assembly kinks.If the device is forcefully advanced against resistance, damage such as kinks may occur.Further evaluation revealed that the pusher assembly was retracted through the proximal end of the introducer sheath.This damage was likely incidental to the reported complaint.During functional testing, the ruby coil was re-sheathed from its returned position within the introducer sheath, then the ruby coil was able to advance out of its introducer sheath but was unable to advance completely out due to the pusher assembly kink.The root cause of resistance during the procedure could not be determined.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: 11694661
• Report Number: 3005168196-2021-00796
• Device Sequence Number: 14311997
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 00814548019116
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021
• 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: RBY2C1460-B
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F96670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/18/2021
• 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