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

Model Number	RBYLP0430
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
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: 3005168196-2021-01094, 3005168196-2021-01095, 3005168196-2021-01096, 3005168196-2021-01097, 3005168196-2021-01098, 3005168196-2021-01099, 3005168196-2021-01100, 3005168196-2021-01101.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak sac in the inferior mesenteric artery (ima) using ruby coil lps, packing coil lps, lp system detachment handle (handle), lantern delivery microcatheter (lantern), non-penumbra microcatheter, and a non-penumbra diagnostic catheter.During the procedure, the physician experienced resistance while advancing a lantern through the diagnostic catheter and the lantern became stuck.The lantern was removed and a new microcatheter was used.The physician then attempted to detach a first packing coil lp using a handle; however, the packing coil lp failed to detach.The physician used a new handle; however, the packing coil lp still failed to detach.A hemostat was used to manually detach the coil.The physician then attempted to advance a second packing coil lp; however, the packing coil lp would not advance past the friction lock within its introducer sheath.The physician attempted to advance a third packing coil lp but, the same issue occurred.A fourth packing coil lp was advanced to the target location but had difficulty detaching.Therefore, the physician used a hemostat to manually detach the coil.A fifth packing coil lp would not advance past the friction lock and consequently, the pusher assembly of the packing coil lp became kinked.The physician then attempted to detach ruby coil lp using a handle but, the coil failed to detach.The coil was then manually detached in the target vessel.The procedure had ended at this point.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: 11848412
• Report Number: 3005168196-2021-01102
• Device Sequence Number: 17085518
• Product Code: HCG
• UDI-Device Identifier: 00815948021822
• UDI-Public: 00815948021822
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021
• 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: 04/02/2025
• Device Model Number: RBYLP0430
• Device Catalogue Number: RBYLP0430
• Device Lot Number: F97178
• 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: 04/21/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Date Report Sent to FDA: 01/01/2005