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

Model Number	RBY4C0630-B
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01708.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior and inferior gluteal arteries using ruby coils, a lantern delivery microcatheter (lantern), and a non-penumbra catheter.It should be noted that the patient's anatomy was tortuous, calcified, and narrowed.During the procedure, the physician successfully implanted one ruby coil in the superior gluteal artery.While advancing the next ruby coil over the hub of the microcatheter, resistance was encountered.However, the distal tip of the ruby coil was able to advance past the hub.The ruby coil was retracted and re-advanced; however, resistance was encountered while advancing the coil over the same location.Subsequently, the physician inadvertently kinked the ruby coil pusher assembly.Therefore, the ruby coil was removed.Next, a ruby coil became stuck during advancement through the lantern; therefore the lantern containing the ruby coil was removed from the patient.Subsequently, a non-penumbra microcatheter was used to successfully implant the same ruby coil.The procedure was completed using two ruby coils and two pod packing coils (pod pcs) to embolize the superior gluteal artery and three ruby coils and two pod pcs to embolize the inferior gluteal artery with the same non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the pusher assembly was kinked and revealed the pusher assembly was fractured.If the ruby coil is advanced against resistance during use, damage such as a kink and subsequent fracture may occur.The root cause of resistance could not be determined.Further evaluation revealed a damage pet lock, a damage introducer sheath, and offset coil winds on the embolization coil.These damages were incidental to the reported complaint and the root cause could not be determined.Evaluation of the returned lantern revealed a functional device.During the functional test, a demonstration ruby coil was advanced through the lantern without an issue.Further evaluation revealed a bend in the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.Penumbra devices 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.This report is associated with mfr report number: 3005168196-2021-01708 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: 12257238
• Report Number: 3005168196-2021-01707
• Device Sequence Number: 3668484
• Product Code: HCG
• UDI-Device Identifier: 00814548018362
• UDI-Public: 00814548018362
• 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,Followup
• Report Date (Section B): 08/24/2021
• 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: RBY4C0630-B
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F89537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/31/2021
• Supplement Report FDA Received Date: 08/24/2021
• 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