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

Model Number	RBY2C0840-A
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	08/26/2020
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: 3005168196-2020-01511.
Event or Problem Description
The patient was undergoing a coil embolization procedure in internal iliac artery using ruby coils, a ruby coil detachment handle (handle), and non-penumbra microcatheter.It was reported that the patient anatomy was extremely tortuous.During the procedure, the physician implanted two ruby coils in the target vessel using the microcatheter.Subsequently, the next ruby coil was packed into the target vessel.While attempting to detach the ruby coil using the handle, the ruby coil kept getting sucked back into the microcatheter.The ruby coil was removed.The physician continued the procedure using another ruby coil.While attempting to detach the ruby coil, the same issue occurred, and the pusher assembly of the ruby coil became kinked.The physician manually detached the ruby coil.The procedure was completed using other ruby coils and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pusher assembly was fractured on its proximal end.The pusher assembly had bends and kinks throughout its length.The embolization coil was detached from the pusher assembly.The pull wire was within the pusher assembly distal detachment tip (ddt) alignment feature.Dried blood was within the pusher assembly ddt.The embolization coil had offset coil winds throughout its length.Conclusions: evaluation of the returned ruby coil revealed that the pusher assembly was fractured on its proximal end, the pusher assembly had bends and kinks throughout its length and the embolization coil was detached and had offset coil winds.These damages were not mentioned in the reported complaint and were likely incidental and may have occurred during packaging the device for return to penumbra.The root cause of the detachment issue during the procedure could not be determined.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 root cause of detachment issue this report is associated with mfr report number: 3005168196-2020-01511.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10553392
• Report Number: 3005168196-2020-01510
• Device Sequence Number: 2842843
• Product Code: HCG
• UDI-Device Identifier: 00814548012988
• UDI-Public: 00814548012988
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 08/26/2020
• 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 Expiration Date: 12/04/2025
• Device Model Number: RBY2C0840-A
• Device Catalogue Number: RBY2C0840
• Device Lot Number: F80878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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