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

Model Number	RBY2C1660-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed an undamaged and a functional device.During functional testing, the ruby coil was unable to be advanced through its introducer sheath due to the dried blood inside the introducer sheath.After the dried blood was flushed out with cavicide disinfectant solution, the ruby coil was able to advance through the introducer sheath and a demonstration lantern without an issue.The dried blood inside the introducer sheath was likely incidental to the complaint.The root cause of the reported complaint 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the abdominal aorta using ruby coils and non-penumbra microcatheters.It was noted that the patient¿s anatomy was tortuous.During the procedure, while attempting to advance a ruby coil into the microcatheter, the ruby coil became stuck at the distal tip of the introducer sheath and, therefore, it was removed.The procedure was completed using new ruby coils, pod packing coils (pod pc), four other coils with the same microcatheters.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11795422
• Report Number: 3005168196-2021-00989
• Device Sequence Number: 11603578
• Product Code: HCG
• UDI-Device Identifier: 00814548019253
• UDI-Public: 00814548019253
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• 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
• Report Date (Section B): 04/12/2021
• 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: RBY2C1660-B
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F101659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/08/2021
• 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