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

Catalog Number	RBY4C0630
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	07/20/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery using ruby coils, a non-penumbra microcatheter, and a non-penumbra guide catheter.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the first ruby coil was advanced into the target location and was not taking the desired shape.While retracting the ruby coil, resistance was encountered.The physician applied excessive force and subsequently the ruby coil unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed from the patient and the coil was flushed out on the back table.The procedure was completed using six non-penumbra coils, the same microcatheter, and the same guide catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pull wire was within the pusher assembly ddt.If the ruby coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and allow the embolization coil to detach from the pusher assembly.The root cause of the resistance could not be determined.Further evaluation of the device revealed kinks throughout the length of the pusher assembly and offset coil winds on the embolization coil.This damage was likely incidental to the compliant.The root cause of the embolization coil not taking its intended shape could not be determined.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.H3 other text : placeholder.

• 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: 15283358
• Report Number: 3005168196-2022-00386
• Device Sequence Number: 12568251
• Product Code: HCG
• UDI-Device Identifier: 00814548018362
• UDI-Public: 814548018362
• 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): 08/30/2022
• 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: RBY4C0630
• Device Lot Number: F00000537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005