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

Catalog Number	RBY4C0204
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	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery using ruby coils, a lantern delivery microcatheter (lantern), a non-penumbra glide catheter, a non-penumbra sheath and a guidewire.During the procedure, the physician successfully placed eight ruby coils.While advancing the next ruby coil through the lantern, the physician experienced difficulty advancing the ruby coil.Therefore, the physician decided to retract and remove the ruby coil.Upon retracting, the ruby coil unintentionally detached in the lantern.It was reported that the physician experienced resistance retracting the ruby coil through the lantern.Therefore, the lantern containing the detached ruby coil was removed.The procedure was completed at this point.There was no report of an adverse effect to the patient.
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, the pull wire was within the distal tip of the pusher assembly.If the ruby coil is retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching from the pusher assembly.The detached embolization coil was not returned for evaluation.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation revealed a fracture and kinks in the pusher assembly and the pull wire was slightly protruded distal to the tip of the pusher assembly.This damage was incidental to the complaint.The kinks and fractures in the pusher assembly likely occurred during packaging for return to penumbra.The root cause of the pull wire protruded the distal tip of the pusher assembly 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.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: 18116473
• Report Number: 3005168196-2023-00506
• Device Sequence Number: 7512441
• Product Code: HCG
• UDI-Device Identifier: 00814548018270
• UDI-Public: 814548018270
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2023
• 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: RBY4C0204
• Device Lot Number: F00007286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 10/17/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005