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

Model Number	RBY2C2860-B
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00065.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary vein using ruby coils, ruby coil detachment handle (handle), and lantern delivery microcatheter (lantern).It was noted that the patient¿s anatomy was tortuous and calcified.During the procedure, the physician successfully detached four ruby coils in the target vessel using the handle.While detaching the next four ruby coils, the physician experienced difficulty detaching the four ruby coils using the handle.It was also reported that handle was clicked more than once to detach the four ruby coils.Subsequently, the physician advanced the ninth ruby coil into the target location and attempted to detach it using a handle; however, the ruby coil failed to detach after multiple attempts to click the slider on the handle.Therefore, the ruby coil and handle were removed.The procedure was completed using a new handle and new ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle revealed a functional device.The handle was tested on a test fixture and performed within specification.The handle was used to detach a demonstration ruby coil without an issue.The nose cone was measure with pin gauges and was measured to be within specification.Further evaluation revealed a piece of pet within the handle body.Evaluation of the returned ruby coil confirmed that the embolization coil was intact with the pusher assembly.Further evaluation revealed that the pull tube was retracted out of the pusher assembly and the pull wire was fractured.The root cause of the pull wire fracture could not be determined; however, this damage contributed to the inability to detach the embolization coil during the procedure.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.Penumbra coils are 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of coils failure to detach.This report is associated with mfr report number: 3005168196-2021-00065 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11149990
• Report Number: 3005168196-2021-00066
• Device Sequence Number: 3472184
• Product Code: HCG
• UDI-Device Identifier: 00814548019314
• UDI-Public: 00814548019314
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2020
• 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 Model Number: RBY2C2860-B
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F87671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/13/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005