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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a ruby coil into the target location and found that it was not the correct size.Therefore, the ruby coil was removed.While advancing the next ruby coil to the target location, the ruby coil became stuck inside the px slim and the physician noticed that the coil was unintentionally detached inside the px slim.Therefore, the px slim containing the ruby coil was removed from the patient and the coil was flushed out of the px slim using saline solution.The procedure was completed using a smaller size ruby coil and the same px slim.There was no report of an adverse effect to the patient.While performing the final radiological control to observe the patency of the right renal artery, the physician reported that part of the ruby coil went through the aneurysmal neck, invading the lumen of the right renal artery.However, no further action was taken.
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: 1.3005168196-2023-0040.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pet lock was intact on the proximal end of the pusher assembly, the pusher assembly was fractured, and the pull wire was retracted from the pusher assembly distal tip.If the device is advanced against resistance, damage such as a kink may occur.Subsequently, if a kinked device is further manipulated, the kink may worsen to a fracture.The fractured segments being separated likely caused the pull wire to retract, detaching the embolization coil.Based on the reported event, the root cause of resistance could not be determined.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.This report is associated with mfr report number: 1.3005168196-2023-00401 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17627955
• Report Number: 3005168196-2023-00400
• Device Sequence Number: 6135699
• Product Code: HCG
• UDI-Device Identifier: 00814548018348
• UDI-Public: 814548018348
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023
• 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 Catalogue Number: RBY4C0415
• Device Lot Number: F00005925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005