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

Model Number	RBYLP0105
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp confirmed the embolization coil was intact with the pusher assembly.Further evaluation revealed the pet lock was not present, the pusher assembly was fractured on its proximal end, and the pull wire was still in its initial position within the ddt.This indicates that the pull wire likely fractured.If this occurs, the pull wire will not retract out of the ddt, and the embolization coil will not detach.Further evaluation revealed pusher assembly kinks.This damage may be incidental to the reported complaint.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 gastric bleed using ruby coil lps, a lp system detachment handle (handle), and non-penumbra microcatheter.During the procedure, while attempting to detach the ruby coil lp by using the handle, the alignment zone had separated on the pusher assembly but the ruby coil lp did not detach.The physician then tried detaching the ruby coil lp manually; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed.The procedure was completed using a new ruby coil lp of the same size, the same handle and the same microcatheter.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: 12530539
• Report Number: 3005168196-2021-02113
• Device Sequence Number: 4230886
• Product Code: HCG
• UDI-Device Identifier: 00815948021730
• UDI-Public: 00815948021730
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 09/24/2021
• 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: 05/12/2026
• Device Model Number: RBYLP0105
• Device Catalogue Number: RBYLP0105
• Device Lot Number: F106205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• 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: 09/21/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005