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

Model Number	RBY4C0860-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
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 ovarian vein using ruby coils and lantern delivery microcatheter (lantern).During the procedure, a ruby coil was stuck and would not advance from the starting position within its introducer sheath; therefore, it was removed.The procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed a kinked introducer sheath.If the introducer sheath is mishandled during use, damage such as this may occur.This damage may have contributed to the reported difficulty advancing the ruby coil out of its introducer sheath during the procedure.During functional testing, the ruby coil was unable to advance through the kink in the introducer sheath.Further evaluation of the device revealed offset coil winds on the embolization coil.This damage was likely a result of forceful advancement against resistance during the procedure.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
• MDR Report Key: 11290239
• Report Number: 3005168196-2021-00234
• Device Sequence Number: 3475757
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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): 01/12/2021
• 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: F97910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/06/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005