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

Catalog Number	RBYLP0210
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior upper gastric artery using ruby coil lps, lp system detachment handle (handle), and a non-penumbra microcatheter.During the procedure, the physician advanced a penumbra coil into the target vessel and attempted to detach it using a handle; however, the coil failed to detach.Therefore, the physician removed the handle and used a new handle to detach the same coil.Next, while attempting to embolize the vessel, the physician noticed the ruby coil lp had unintentionally detached inside the microcatheter.Therefore, the physician used saline to flush the microcatheter and push the detached ruby coil lp into the vessel.Subsequently, while advancing another ruby coil lp through the microcatheter, the physician noticed the ruby coil lp started to take its intended shape within the microcatheter.Therefore, ruby coil lp was removed.The procedure was completed using additional ruby coil lps and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil lp revealed offset coil winds on the embolization coil.This damage typically occurs due to advancement against resistance.The microcatheter used in the procedure is larger than intended to deliver a ruby coil lp.If the ruby coil lp is advanced through a microcatheter with a larger id than intended, resistance will likely be experienced.Based on the reported event, this is likely what contributed to the resistance experienced during the procedure and offset coil winds observed on the returned device.Further evaluation of the device revealed kinks on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.Evaluation of the second returned ruby coil lp confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated, and the pull wire was retracted.If the pet lock is separated and the pull wire retracted, the embolization coil will likely detach.This likely contributed to the reported coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed an ovalization on the introducer sheath.This damage was likely incidental to the complaint.Penumbra products 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.H3 other text : placeholder.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16052428
• Report Number: 3005168196-2022-00589
• Device Sequence Number: 15053801
• Product Code: HCG
• UDI-Device Identifier: 00815948021761
• UDI-Public: 815948021761
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023
• 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 Catalogue Number: RBYLP0210
• Device Lot Number: F00002243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• 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: 12/02/2022
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005