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

Model Number	RBY2C2060-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil and a non-penumbra microcatheter.During the procedure, the physician experienced resistance while advancing a ruby coil halfway through the microcatheter.Subsequently, the physician removed the ruby coil to check if the microcatheter was still placed in its correct position.After confirming that the microcatheter was still placed in its correct position and that the microcatheter could be flushed without any problem, the physician re-inserted the ruby coil into the microcatheter.However, while advancing the ruby coil halfway through the microcatheter, the physician experienced resistance again and decided to retract it.While retracting the ruby coil, resistance was encountered and subsequently, the ruby coil detached from its pusher assembly with part of the ruby coil outside the patient and the other part inside the microcatheter.Therefore, the physician was able to pull the detached ruby coil out of the microcatheter.The procedure was completed using two additional ruby coils, two pod packing coils, and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the embolization coils proximal constraint sphere was within the pusher assembly ddt, and the embolization coil was unraveled due to the sr wire being fractured.If the device is forcefully retracted against resistance, the sr wire may fracture, and the embolization coil will unravel.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed pusher assembly bends.This damage was likely incidental to the reported complaint.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.

• 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: 12384717
• Report Number: 3005168196-2021-01928
• Device Sequence Number: 3476123
• Product Code: HCG
• UDI-Device Identifier: 00814548013077
• UDI-Public: 00814548013077
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021
• 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: RBY2C2060-A
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F94288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• 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: 08/03/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2019
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 01/01/2005