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

Catalog Number	RBY2C2860
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric vein using a ruby coil, a non-penumbra microcatheter, a guiding sheath, and a balloon guide catheter.During the procedure, the physician successfully implanted one ruby coil into the target vessel using the microcatheter.Next, while advancing another ruby coil through the proximal end of the microcatheter, the physician experienced resistance.Therefore, the microcatheter containing the ruby coil was removed.On the back table, upon pulling the ruby coil out from the microcatheter, the physician noticed the ruby coil was no longer attached to the pusher assembly and had unintentionally detached inside the microcatheter.The physician flushed the microcatheter and removed the detached ruby coil.The procedure was competed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned; however, on 18-jul-23 the device was received.Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the proximal end of the pusher assembly was fractured, the pet lock was not present, and the pull wire was retracted completely out of the pusher assembly.If the ruby coil is advanced against resistance, damage such as a fracture on the pusher assembly may occur.If the pusher assembly is fractured, the pull wire will retract, and the embolization coil will detach from the pusher assembly.The root cause of the resistance could not be determined.Further evaluation revealed bends along the length of the pusher assembly.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 17375331
• Report Number: 3005168196-2023-00348
• Device Sequence Number: 7061658
• Product Code: HCG
• UDI-Device Identifier: 00814548019314
• UDI-Public: 814548019314
• 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): 08/18/2023
• 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: RBY2C2860
• Device Lot Number: F00006194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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