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

Model Number	RBY4C0860-A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
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: 3005168196-2021-01365.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a px slim delivery microcatheter (px slim), a ruby coil and a ruby coil detachment handle (handle).During the procedure, the physician advanced a ruby coil to the target vessel using a px slim and attempted to detach it using a handle; however, the ruby coil failed to detach.Subsequently, the pusher assembly of the ruby coil became stuck within the handle.Therefore, the ruby coil and the handle were removed.The procedure was completed using a new ruby coil, a new handle and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned handle confirmed that the proximal end of the ruby coil pusher assembly was stuck inside.If the handle is repeatedly actuated during the attempt to detach the coil, damage such as this may occur.During the functional test, the proximal end of the ruby coil pusher assembly was removed from the handle''s actuator.The handle was then attempted to be functionally tested on the handle fixture and did not function as intended.A clicking sound was observed, but the actuator was not gripping the pull tube, and no further testing could be performed.Evaluation of the returned ruby coil revealed a fractured pull tube inside the returned handle.The rest of the pusher assembly was not returned for evaluation.Therefore, the root cause of the reported detachment issue could not be determined.Penumbra devices are visually inspected during in-process inspection and during quality inspection after manufacturing section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of reported detachment issue on the ruby coil this report is associated with mfr report number: 1.3005168196-2021-01365 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: 12025791
• Report Number: 3005168196-2021-01366
• Device Sequence Number: 11578220
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• 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): 08/27/2021
• 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: RBY4C0860-A
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F102613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005