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

Model Number	RBY4C0406-B
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
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: 3005168196-2021-00482.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right pulmonary artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil into the vessel using the lantern; however, the ruby coil would not anchor against the vessel and take its intended shape therefore, it was removed.The physician then advanced a new ruby coil into the target location; however, the same issue occurred.Therefore, the ruby coil was removed.The physician decided to end the procedure at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned first ruby coil revealed that the coil had its intended shape.During the functional test, the ruby coil was advanced through its introducer sheath, and the embolization coil shape was present.The reported complaint could not be confirmed.Evaluation of the returned second ruby coil revealed that the coil had its intended shape.During the functional test, the ruby coil was advanced through its introducer sheath, and the embolization coil shape was present.The reported complaint could not be confirmed.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.This report is associated with mfr report number: 3005168196-2021-00482.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11466943
• Report Number: 3005168196-2021-00483
• Device Sequence Number: 19843933
• Product Code: HCG
• UDI-Device Identifier: 00814548018331
• UDI-Public: 00814548018331
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021
• 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: RBY4C0406-B
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F98320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Date Report Sent to FDA: 01/01/2005