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

Model Number	RBY2C2457-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right renal artery using a ruby coil, a lantern delivery microcatheter (lantern), non-penumbra stents, and a non-penumbra sheath.During the procedure, the physician placed two stents in the vessel and then advanced a lantern through the stents and into the aneurysm.Next, while advancing a ruby coil into the aneurysm, the physician noticed the coil was not taking its intended shape.Therefore, the physician decided to retract the ruby coil to reposition it.While retracting the ruby coil, the physician inadvertently retracted the lantern out of the aneurysm.The physician then attempted to advance the lantern over the ruby coil and back into the aneurysm; however, the ruby coil did not provide adequate stability and the physician decided to retract the coil to start over.While retracting, the ruby coil unintentionally detached.It was reported that the ruby coil may have gotten caught on the edge of the stent struts and began taking shape.It was also reported that approximately a few centimeters of the detached ruby coil was in the aneurysm and the rest of the coil was hanging within the sheath.The physician attempted to use a snare device and forceps to remove the detached ruby coil; however, the attempts were unsuccessful.Therefore, the physician used the forceps to break and remove the detached ruby coil that was hanging within the sheath by shortening the length.The physician was able to remove most of the remaining coil, only leaving a short, thin section outside of the aneurysm.It was reported that the aneurysm was not occluded.The physician decided to end the procedure at this point.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
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13609409
• Report Number: 3005168196-2022-00081
• Device Sequence Number: 11259840
• Product Code: HCG
• UDI-Device Identifier: 00814548019291
• UDI-Public: 00814548019291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: RBY2C2457-B
• Device Catalogue Number: BY2C2457
• Device Lot Number: F109803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male