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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Failure to Fold (1255); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using a ruby coil, a lantern delivery microcatheter (lantern), and an angiographic catheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the ruby coil through the lantern and into the target vessel.However, the ruby coil would not form into the target vessel.The physician then made a second attempt to place the ruby coil into the target vessel; however, the ruby coil unintentionally detached.Therefore, the angiographic catheter containing the lantern and ruby coil was removed.The procedure was completed using a new ruby coil, the same lantern, and the same angiographic catheter.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 pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly.If the pet lock is forcefully manipulated during use, the pet lock may separate.If this occurs, the pull wire may retract from the distal tip of the pusher assembly and the embolization coil may detach from the pusher assembly.The detached embolization coil was not returned for evaluation; therefore, the reported embolization coil did not form the desired shape could not be confirmed.Further evaluation of the device revealed multiple kinks and fractures on the pusher assembly and the introducer sheath.This damage was not mentioned in the complaint and likely incidental to the reported 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.

• Brand Name: RUBY COIL
• 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: 16964348
• Report Number: 3005168196-2023-00241
• Device Sequence Number: 5237991
• Product Code: HCG
• UDI-Device Identifier: 00814548018348
• UDI-Public: 814548018348
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023
• 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: RBY4C0415
• Device Lot Number: F00005602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005