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

Model Number	RBYLP0102
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed that the embolization coil was intact with the pusher assembly.Further evaluation revealed that the pusher assembly had multiple kinks and fractures.If the device is manipulated at extreme angles during use, damage such as kinks and fractures may occur.If the pusher assembly is kinked, the pull wire may become pinned inside the hypotube, and resistance may be experienced.This damage may have contributed to resistance during attempts to detach the embolization coil during the procedure and the functional test.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 to treat a left humerus tumor using ruby coil lps, a lp system detachment handle (handle), and non-penumbra microcatheter.During the procedure, the physician accessed the left axillary and brachial artery, where the branches were feeding the tumor, using the microcatheter.A ruby coil lp was advanced to desired tumor branch but subsequently would not detach with the handle.Multiple attempts were performed without detachment.Therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp and the same handle.After the ruby coil lp was removed from patient, the hospital interventional radiology (ir) tech broke and pulled the pusher assembly to manually detach the coil, but the ruby coil lp was unable to detach.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12628406
• Report Number: 3005168196-2021-02283
• Device Sequence Number: 13813710
• Product Code: HCG
• UDI-Device Identifier: 00815948021723
• UDI-Public: 00815948021723
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• 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
• Report Date (Section B): 10/13/2021
• 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: 05/27/2026
• Device Model Number: RBYLP0102
• Device Catalogue Number: RBYLP0102
• Device Lot Number: F106697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• 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: 09/20/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005