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

Model Number	RBY2C1240-A
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	03/08/2021
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 for a vessel sacrifice in the renal artery using a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, while the physician advanced a ruby coil into the small aneurysm between the feeding renal polar artery and the big aneurysm, the physician noticed that the aneurysm was open on the distal side; therefore, the ruby coil would not stay in place.Subsequently, the physician retracted the lantern to attempt to position the ruby coil proximal to the aneurysm into the feeding renal polar artery.However, due to extremely high flow in the artery, the ruby coil would not anchor, and the physician decided to remove the ruby coil.While retracting the ruby coil into its introducer sheath, the physician experienced resistance.Subsequently, the physician was unable to retract the last five centimeters of the ruby coil into its introducer sheath.The physician then attempted to gently pull the ruby coil a little more and heard a sound.It was noticed that the ruby coil unintentionally detached from its pusher assembly, with approximately five centimeters of the ruby coil hanging out of its introducer sheath.This all occurred when the ruby coil was outside of the patient.The procedure was completed using a pod coil, a ruby coil, a pod packing coil, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly and revealed that the ddt was separated from the pusher assembly.If the ruby coil is forcefully retracted against resistance during use, the ddt may become separated from the pusher assembly, and result in the embolization coil detaching from the pusher assembly.Further evaluation of the device revealed that the embolization coil had offset coil winds.The root cause of this damage could not be determined; however, this damage likely contributed to the resistance experienced while retracting the ruby coil into the introducer sheath during the procedure.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11615229
• Report Number: 3005168196-2021-00683
• Device Sequence Number: 14234234
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021
• 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 Expiration Date: 10/19/2024
• Device Model Number: RBY2C1240-A
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F72416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005