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

Catalog Number	RBY2C2060
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	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery (iia) using ruby coils, pod packing coils (pod pc), and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance while advancing a ruby coil as the first coil in the middle of the lantern.Subsequently, the physician decided to remove the ruby coil; however, while retracting, the physician noticed the ruby coil had unintentionally detached inside the lantern.Therefore, the lantern containing the detached ruby coil was removed and the coil was flushed out.The physician then reinserted the same lantern and placed a new ruby coil in the target vessel.Next, while advancing a pod pc through the lantern, the physician experienced resistance again in the middle of lantern; therefore, the physician decided to remove the pod pc.However, upon retracting, the pod pc had unintentionally detached inside the lantern.Therefore, the lantern containing the detached pod pc was removed.The procedure was completed using new pod pc, three non-penumbra coils, and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pusher assembly confirmed that the embolization coil was detached.Evaluation revealed that the pusher assembly was fractured, and the pull wire was retracted from the ddt.Based on the reported event, the root cause of the fracture could not be determined; however, this damage likely contributed to the embolization coil detachment during the procedure.The detached embolization coil was not returned for evaluation.Further evaluation of the device revealed kinks on the pusher assembly.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.This report is associated with mfr report number: 3005168196-2022-00453.

• 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: 15495973
• Report Number: 3005168196-2022-00452
• Device Sequence Number: 5171180
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 814548019284
• 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): 09/27/2022
• 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: RBY2C2060
• Device Lot Number: F111433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• 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: 09/01/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005