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

Model Number	RBY2C1660-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly, the pet lock was intact, and the pull wire was slightly retracted from its initial position within the ddt.If the ruby coil is forcefully retracted against resistance, the pusher assembly may become elongated and the pull wire may retract enough to allow the coil to detach from the pusher assembly.The detached embolization coil was not returned for evaluation; therefore, functional testing could not be performed.The reported resistance experienced during the procedure could not be determined.Evaluation of the returned ruby coil revealed that the pull wire was advanced distal to the pusher assembly ddt, and the pusher assembly was fractured and kinks near the fractured location.If the device is forcefully advanced against resistance, damage such as this may occur.The pusher assembly was fractured; therefore, functional testing could not be performed.The reported resistance experienced during the procedure could not be determined.Further evaluation of the device revealed an offset coil wind on its embolization coil.This damage was likely incidental to the complaint.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.Conclusions code: (b)(4).The investigation findings do not lead to a clear conclusion about the root cause of the reported complaint due to the return condition.This report is associated with mfr report number: 3005168196-2021-00197.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using ruby coils and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the first ruby coil became stuck at the distal tip of its introducer sheath; therefore, the ruby coil was removed.The physician then continued with the procedure using a second ruby coil.However, the same issue occurred.Therefore, the ruby coil was removed.The procedure was completed using three new ruby coils.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: 11263299
• Report Number: 3005168196-2021-00198
• Device Sequence Number: 19011450
• 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): 01/05/2021
• 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: F86951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• 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: 01/05/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005