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

Model Number	RBY4C0305-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
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.This report is associated with mfr report number: 3005168196-2020-01917.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) off of the superficial femoral artery (sfa) using ruby coils, a lantern delivery microcatheter (lantern), and a guidewire.During the procedure, the physician felt resistance when approximately seventy-five percent of the ruby coil was advanced out of the lantern.When the physician attempted to remove the ruby coil, it detached into the patient's vessel.Subsequently, a snare device was used and the ruby coil was successfully removed.Next, the physician felt resistance when approximately seventy-five percent of the next ruby coil was advanced out of the lantern.When the physician attempted to remove the ruby coil, it detached into the patient's vessel.However, the physician was able to remove the lantern and flush the ruby coil out on the back table.The procedure was completed by re-inserting the same lantern and using another ruby coil.It was also reported that, while analyzing the angiogram images, the target location was revealed to be no more than 2 mm in size.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned ruby coil confirmed that the embolization coil was detached.Further evaluation revealed that the pusher assembly was fractured and had multiple kinks along its length.If the device is forcefully advanced against resistance, damage such as a kink and subsequent fracture may occur.If the pusher assembly fractures, the coil will likely detach.Additional damage was incurred to the coil when snared from the patient.Based on the reported event, the resistance experienced during the procedure was likely due to the coil being too large for the aneurysm.Evaluation of the second returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pusher assembly was fractured near the proximal end of the introducer sheath.If the mid-joint is retracted through the introducer sheath friction lock, resistance may be experienced during advancement, and damage such as a kink and subsequent fracture may occur.If the pusher assembly fractures, the coil will likely detach.The damage on the returned device does not align with the reported issue; therefore, the root cause could not be determined.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: 1.3005168196-2020-01917, 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: 10814348
• Report Number: 3005168196-2020-01918
• Device Sequence Number: 1114651
• Product Code: HCG
• UDI-Device Identifier: 00814548018317
• UDI-Public: 00814548018317
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 10/12/2020
• 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: RBY4C0305-B
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F88975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005