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	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly and revealed that the pe fibers were fractured, the proximal constraint sphere was detached from the proximal end of the embolization coil.The probable cause of the failure was likely due to forceful manipulated against resistance.If the device is forcefully manipulated against resistance, the pe fibers may fracture.If the pe fibers fracture, the proximal constraint sphere may detach from the embolization coil and the embolization coil may detach from the pusher assembly.Due to the returned damage, the device could not be functionally tested.The root cause of the resistance could not be determined.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the portal vein using ruby coils and a non-penumbra microcatheter.It should be noted that the patient's anatomy was tortuous.During the procedure, six ruby coils were successfully implanted into the target location.While advancing the next ruby coil through its introducer sheath, the coil detached.Therefore, the ruby coil was removed.The procedure was completed using three ruby coils, five pod packing coils (pod pcs), a pod coil, ten non-penumbra coils, and the same 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: 12573705
• Report Number: 3005168196-2021-02199
• Device Sequence Number: 3487637
• Product Code: HCG
• UDI-Device Identifier: 00814548019291
• UDI-Public: 00814548019291
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/04/2021
• 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 Model Number: RBY2C2457-B
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F102474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• 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: 09/09/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005