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

Catalog Number	RBY4C0860
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an endoleak in the inferior mesenteric artery (ima) using ruby coils, pod packing coils (pod pcs), a ruby coil detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician successfully implanted the first ruby coil into the target vessel using the handle.The physician then advanced the second ruby coil into the target vessel and attempted to detach it using the handle; however, the ruby coil failed to detach.The physician then attempted to manually detach the ruby coil, but the ruby coil would still not detach.Therefore, the physician decided to remove the ruby coil.While retracting the ruby coil, it unintentionally detached within the microcatheter.Therefore, the physician used the pusher assembly of the ruby coil to push the detached ruby coil successfully into the target vessel.Next, the physician advanced a third ruby coil into the target vessel and attempted to detach it using the handle; however, the ruby coil failed to detach.The physician then used a new handle to successfully detach the ruby coil into the target vessel.After that, the physician advanced a pod pc into the target vessel, and successfully detached it using the second handle.A second pod pc was subsequently advanced into the target vessel and the physician attempted to detach it using the second handle; however, the pod pc failed to detach.The physician then manually detached the pod pc into the target vessel.It was reported that the same issue occurred with an additional pod pc; therefore, the pod pc was also successfully manually detached into the target vessel.The procedure ended at this point.There was no report of an adverse effect to the patient.
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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16153814
• Report Number: 3005168196-2023-00021
• Device Sequence Number: 17991070
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 814548018393
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2023
• 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 Catalogue Number: RBY4C0860
• Device Lot Number: F00000247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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: 63 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005