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

Model Number	RBY2C0435-B
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
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.
Event or Problem Description
The patient was undergoing a thoracic duct embolization procedure using ruby coils, and a non-penumbra microcatheter.During the procedure, the physician placed a ruby coil in the target location using the microcatheter.While advancing the next ruby coil through the microcatheter, the ruby coil unintentionally detached inside the microcatheter and subsequently, the physician noticed that the microcatheter was ovalized.Therefore, the microcatheter containing the detached ruby coil was removed.The physician was unable to obtain access again due to the type of embolization procedure.Therefore, the physician decided to end the procedure at this point and planned to bring the patient back in on a later date.There was no report of an adverse effect to this patient.
Additional Manufacturer Narrative
Results: the pe fiber was fractured, and the embolization coil was unraveled.Conclusions: evaluation of the returned ruby coil embolization coil revealed that the pe fibers were fractured.If the ruby coil is forcefully manipulated against resistance during use, damage such as a pe fiber fracture may occur.This will result in the embolization coil detaching from its pusher assembly unintentionally.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: 10848349
• Report Number: 3005168196-2020-02009
• Device Sequence Number: 16748921
• Product Code: HCG
• UDI-Device Identifier: 00814548018614
• UDI-Public: 00814548018614
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 10/22/2020
• 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 Model Number: RBY2C0435-B
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F97516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Date Report Sent to FDA: 01/01/2005