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

Model Number	RBY4C0315-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
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 deep femoral artery using ruby coils and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, a ruby coil became stuck inside the proximal to middle end of the flushed microcatheter, after the entire length of the coil was inside the microcatheter.The physician decided to remove the ruby coil and inadvertently broke the pusher wire and detached the coil inside the microcatheter.It was reported that the ruby coil detached in the same location it had been stuck.Therefore, the microcatheter containing the detached coil was removed and the ruby coil was flushed out.The procedure was completed using another ruby coil with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the pusher assembly was fractured, and the embolization coil was detached from the pusher assembly.If the device is forcefully advanced against resistance, the pusher assembly may become kinked and subsequent fracture may occur.If the pusher assembly is fractured and the pull wire is retracted from the pusher assembly ddt, the embolization coil will detach from the pusher assembly.Due to the returned damage, functional testing could not be performed; therefore, the root cause of the resistance during the procedure could not be determined.Further evaluation of the device revealed a pusher assembly kink and offset coil winds on the embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned non-penumbra microcatheter revealed an undamaged device.During functional testing, a demonstration ruby coil was able to advance through the non-penumbra microcatheter without issue.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: 11487903
• Report Number: 3005168196-2021-00501
• Device Sequence Number: 11713511
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• 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): 02/17/2021
• 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: RBY4C0315-B
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F89855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005