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

Model Number	RBYLP0430
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
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.This report is associated with mfr report numbers: 3005168196-2020-00472, 3005168196-2020-00473, 3005168196-2020-00474, 3005168196-2020-00475, 3005168196-2020-00477, 3005168196-2020-00478, 3005168196-2020-00479, 3005168196-2020-00480.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the abdominal aortic using packing coil lps, ruby coil lps, lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a packing coil lp to the target vessel using the microcatheter and made multiple attempts to detach it using the handle.However, the attempts were unsuccessful, and it was observed that the black alignment zone on the handle had minimal separation; subsequently, the physician used their fingers to pin and pull the pusher assembly of the packing coil lp to manually detach it.In the middle of the procedure, a ruby coil lp (f94634) was found kinked upon removal from the packaging hoop.The damage to the ruby coil lp was found prior to use, and therefore, it was not used in the procedure.The physician then continued the procedure, and the issue with the packing coil lp occurred with three additional packing coil lps and two ruby coils lps.Another handle was opened and used with attempts to detach the coils, but it is unknown at which point the second handle was used; therefore, the coils were also manually detached using the pin and pull technique.It was reported that one of the handle made a weak sound upon pulling the trigger.In addition, the distal tip of the microcatheter was not initially visible, which led to the pusher assemblies of the ruby coil lps exiting the microcatheter and kinking in the coil pack.Once the physician was closer to the origin of the inferior mesenteric artery (ima), the tip of the microcatheter became visible.The procedure was completed using two additional ruby coil lps, a third 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: 9908826
• Report Number: 3005168196-2020-00476
• Device Sequence Number: 3131605
• Product Code: HCG
• UDI-Device Identifier: 00815948021822
• UDI-Public: 00815948021822
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2024
• Device Model Number: RBYLP0430
• Device Catalogue Number: RBYLP0430
• Device Lot Number: F94630
• Was Device Available for Evaluation?: No
• 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: 03/05/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005