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

Catalog Number	RBY4C0415
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	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery using ruby coils and a lantern delivery microcatheter (lantern).It should be noted that the patient's anatomy was tortuous.During the procedure, the physician successfully implanted five ruby coils.While advancing the next ruby coil near the distal end of the lantern, resistance was encountered.The physician decided to retract the ruby coil slowly and encountered resistance again.Subsequently, the ruby coil unintentionally detached inside the lantern.Therefore, the lantern containing the detached ruby coil was removed.The ruby coil was flushed out on the back table.It was also reported that the physician damaged the ruby coil pusher wire.The physician attempted to re-advance the same lantern into the target location and reported that it was unable to advance.Therefore, the lantern was removed.The procedure was completed using a non-penumbra microcatheter and six non-penumbra coils.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 confirmed that the embolization coil was detached from the pusher assembly.If the ruby coil is retracted against resistance, damage such as this may occur.Further evaluation of the device revealed that the pusher assembly was kinked and fractured, the pull wire was retracted from the fractured location on the pusher assembly and the embolization coil had offset coil winds.Based on the reported event, this damage was likely incidental to the complaint.The pusher assembly was damaged by the physician as mentioned in the complaint.Due to the returned damage, the root cause of the resistance experienced during the procedure 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.

• 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: 14253717
• Report Number: 3005168196-2022-00195
• Device Sequence Number: 12068083
• 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): 05/13/2022
• 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: RBY4C0415
• Device Lot Number: F110659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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: 2 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005