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

Model Number	RBYLP0210
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the first ruby coil lp confirmed that the embolization coil was intact with the pusher assembly.Evaluation also revealed that the pet lock was separated on the proximal end of the pusher assembly, and the pull wire was in its original position within the ddt.The pet lock separation likely occurred during the attempt to detach the embolization coil during the procedure.The root cause of the pull wire in its original position could not be determined.During the functional test, the ruby coil lp was unable to be detached using the returned handle and a demonstration handle.Further evaluation of the device revealed pusher assembly kink and offset coil winds throughout the embolization coil.This damage was likely incidental to the complaint.Evaluation of the second ruby coil lp confirmed that the embolization coil was intact with the pusher assembly.Evaluation also revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was in its original position within the ddt and coagulated blood was present within the ddt.The pet lock separation likely occurred during the attempt to detach the embolization coil during the procedure.The root cause of the pull wire in its original position could not be determined.The coagulated blood was likely incidental.During the functional test, the ruby coil lp was unable to be detached using the returned handle and a demonstration handle.Further evaluation of the device revealed offset coil winds along the length of the embolization coil.This damage was likely incidental to the complaint.Evaluation of the returned handle revealed a functional device.During the functional test, the handle was test on the handle fixture and passed within specification.The handle was then used to detach a demonstration coil without an issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.(b)(4).This report is associated with mfr report numbers: 3005168196-2021-02107, 3005168196-2021-02108.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coil lps, a lp system detachment handle (handle) and a lantern delivery microcatheter (lantern).During the procedure, the physician placed a ruby coil lp in the target location using the microcatheter and attempted to detach it using a handle; however, the ruby coil lp failed to detach.It was reported that the handle made a clicking sound but the ruby coil lp would not detach from the pusher assembly.The physician then attempted to detach the ruby coil lp by using a hemostat, but the ruby coil lp still failed to detach.Therefore, the ruby coil lp was removed.Afterwards, the physician advanced another ruby coil lp into the target location using the microcatheter and attempted to detach it using the same handle; however, the same issue occurred.The physician also tried detaching the ruby coil lp by using a hemostat; however, the ruby coil lp failed to detach.Therefore, the ruby coil lp was removed.The procedure was completed using ruby coils of a larger size, a ruby coil detachment handle, and the same lantern.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: 12517040
• Report Number: 3005168196-2021-02106
• Device Sequence Number: 19063565
• Product Code: HCG
• UDI-Device Identifier: 00815948021761
• UDI-Public: 00815948021761
• 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): 09/22/2021
• 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: RBYLP0210
• Device Catalogue Number: RBYLP0210
• Device Lot Number: F106208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• 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: 08/28/2021
• Initial Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005