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

Model Number	RBY2C0630-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
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: 3005168196-2021-00023.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, a ruby coil would only advance approximately halfway through the lantern and would not advance any further.Therefore, both the ruby coil and lantern were removed.The procedure was completed using additional ruby coils and a new non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned lantern revealed ovalizations on the distal shaft.If the device is forcefully pinched or gripped during use, damage such as an ovalization may occur.During functional testing, resistance was experienced while attempting to advance a demonstration ruby coil through the lantern due to the ovalization.The ovalization likely contributed to the resistance experienced during the procedure and the functional test.Evaluation of the returned ruby coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the ruby coil could not advance at all within its introducer sheath due to the offset coil winds.Penumbra coils and catheters 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.This report is associated with mfr report number: 3005168196-2021-00023.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/28/2021: 1.Section b.Box 5.Describe event or problem.This report is associated with mfr report number: 3005168196-2021-00023.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gluteal artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, a ruby coil would only advance approximately halfway through the lantern and would not advance any further.Therefore, both the ruby coil and lantern were removed.The procedure was completed using additional ruby coils and a new non-penumbra microcatheter.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: 11125336
• Report Number: 3005168196-2021-00024
• Device Sequence Number: 642635
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 12/10/2020
• 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 Expiration Date: 06/04/2024
• Device Model Number: RBY2C0630-A
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F69969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 01/14/2005
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/13/2021; 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005