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

Catalog Number	RBY2C1660
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	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed that the embolization coil was detached from the pusher assembly.Evaluation revealed that the pusher assembly was fractured, was kinked throughout its length, and the pull wire was retracted out of the pusher assembly distal tip.Based on the reported complaint, this damage was incidental and occurred during packaging for return to penumbra.Due to the returned damage, the device could not be functionally tested for the reported issue.Therefore, the root cause of the reported resistance and coil detachment during the procedure 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 internal iliac artery (iia) using ruby coils and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was moderately tortuous and moderately calcified.During the procedure, the physician successfully implanted a ruby coil into the target vessel using the microcatheter.While advancing the second ruby coil into the microcatheter, the physician experienced resistance but continued to advance the ruby coil.While advancing the ruby coil through the mid-shaft of the microcatheter, resistance was encountered, and the ruby coil stopped advancing.The physician then pulled the pusher assembly of the ruby coil back and noticed that the ruby coil had unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed.It was reported that the ruby coil was flushed out of the microcatheter.The pusher assembly of the ruby coil was reported to be damaged while preparing for return.The procedure was completed using a total of nine additional ruby coils and pod packing coils (packing coil), along with the same microcatheter.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20412806
• Report Number: 3005168196-2024-00343
• Device Sequence Number: 8390414
• Product Code: HCG
• UDI-Device Identifier: 00814548019253
• UDI-Public: 00814548019253
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/09/2024
• 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: RBY2C1660
• Device Lot Number: F00010093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2024
• 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: 09/12/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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: 78 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005