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

Model Number	RBYLP0415
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the ruby coil lp revealed that the embolization coil was intact with the pusher assembly, and the complaint was confirmed.Evaluation revealed that the pet lock was separated, and the pull wire was fractured off the proximal end of the pusher assembly.This damage likely occurred during the attempts to detach the embolization coil manually with a hemostat.Based on the returned condition, the root cause of the reported complaint could not be determined.Further evaluation revealed multiple kinks in the pusher assembly.This damage was incidental to the reported complaint and the root cause could not be determined.However, if these kinks were present during the procedure, they may have contributed to friction between the pull wire and the inner lumen of the pusher assembly and prevented the embolization coil from being detached.Penumbra coils are visually 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.(b)(4).This report is associated with mfr report numbers: 3005168196-2021-02434, 3005168196-2021-02436.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) and inferior mesenteric artery (ima) endoleak sac using packing coil lps, ruby coil lps, a lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a packing coil lp into the target location and attempted to detach it using a handle; however, the packing coil lp failed to detach.The physician then attempted to manually detach the packing coil lp using a hemostat, but the coil still would not detach.Therefore, the packing coil lp was removed.Subsequently, the physician was unable to detach two ruby coil lps in the target location using the same handle.Therefore, the handle was removed.The physician attempted to detach the same ruby coils using a new handle, but the two ruby coil lps would not detach.It was also reported that the physician attempted to manually detach the two ruby coil lps using a hemostat; however, the attempt was unsuccessful.Therefore, the two ruby coil lps and handle were removed.The procedure was completed using new lp coils with a hemostat 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: 12725691
• Report Number: 3005168196-2021-02435
• Device Sequence Number: 17303519
• Product Code: HCG
• UDI-Device Identifier: 00815948021815
• UDI-Public: 00815948021815
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 10/31/2021
• 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: 06/15/2026
• Device Model Number: RBYLP0415
• Device Catalogue Number: RBYLP0415
• Device Lot Number: F107120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• 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: 10/07/2021
• Initial Report FDA Received Date: 10/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Date Report Sent to FDA: 01/01/2005