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

Model Number	RBY2C1260-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician implanted two ruby coils in the splenic aneurysm.After advancing the third ruby coil approximately 20cm, the pusher assembly of the ruby coil became stuck at the rotating hemostasis valve (rhv).The physician had experienced resistance, and the ruby coil was unable to advance further in the px slim.Subsequently, the ruby coil was removed.The physician then advanced the ruby coil into a bowl of saline to rinse off and noticed the ruby coil had detached on the back table.Therefore, the ruby coil was not used for the remainder of the procedure.The procedure was completed using two new ruby coils and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil was unable to confirm the detached embolization coil.Evaluation revealed that the embolization coil was intact with its pusher assembly.Further evaluation revealed the pusher was retracted entirely out of the sheath was kinked.The embolization coil also had offset coil winds along its length.This damage was likely incidental to the reported complaint.The ruby coil was stuck within its introducer sheath and could not be re-sheathed.Therefore, functional testing could not be performed.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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.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: 11263424
• Report Number: 3005168196-2021-00201
• Device Sequence Number: 1165532
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021
• 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: RBY2C1260-A
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F100994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005